WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
W/L 30-10
July 14, 2010
Earl R. Fender
President and CEO
VertiFlex, Inc.
1351 Calle Avanzado
San Clemente, California 92673-6351
Re: Dynabolt™ Dynamic Stabilization System
Dear Mr. Fender:
Refer to EC090517 / E003 when replying to this letter.
During an inspection of your firm, located at the above shown address, from February 2, 2010 through February 11, 2010, an Investigator from the United States Food and Drug Administration ( henceforth “FDA” ) learned that your firm is marketing the Dynabolt™ Dynamic Stabilization System ( henceforth ”Dynabolt™” ) in the United States without marketing clearance or approval which is in violation of the Federal Food, Drug, and Cosmetic Act (henceforth “the Act”).
The Office of Compliance in the Center for Devices & Radiological Health at FDA reviewed instructions-for-use, design documents, and marketing materials for the Dynabolt™ device. The product is a device within the meaning of Section 201 (h) of the Federal Food, Drug, and Cosmetic Act. The Dynabolt™ device was cleared under K073143 under the name, Modified VertiFlex® Spinal Screw System. It was cleared with the following intended use:
When used as a pedicle screw fixation system in skeletally mature patients, the Modified VertiFlex® Spinal Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system, the Modified VertiFlex® Spinal Screw System is indicated in patients who are receiving fusions with autogenous graft, who are having the device fixed or attached to the lumbar or sacral spine, and who are having the device removed after the development of a solid fusion mass.
Off-label Promotion
You are promoting and marketing the Dynabolt™ for indications not cleared under K073143.
These include, but are not limited to:
• Degenerative disc disease as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
• Severe spondylolisthesis ( Grades 3 and 4 ) of the L5-S1 vertebra
• Trauma ( for example, fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures
• Tumor
Additionally, according to documentation provided during the establishment inspection, the Dynabolt™ (K073143) is indicated for use with components of the Silverbolt and/or Mainframe systems ( K073245). The Dynabolt™ was not cleared for use with these components and this use requires the submission of a new 510(k) to demonstrate substantially equivalent mechanical performance to legally marketed devices.
Because of these reasons, the device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval ( henceforth “PMA” ) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption ( henceforth “IDE” ) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), in that a notice or other information respecting the modification or new intended use of the device was not provided to the FDA as required by section 510(k) of the Act, 21 U.S.C. 360(k).
FDA’s Office of Compliance requests that VertiFlex, Inc. immediately cease the dissemination of promotional materials for the Dynabolt™ device the same as or similar to those described above. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and /or civil money penalties.
It is recommended that you provide additional information to clarify the composition of your devices cleared under the following 510(k)s: K062670, K073143, K073143. It is recommended that you include a table of how the currently used trade names apply to the components of the devices as well as whether any of the device systems share components.
Medical Device Reporting
Our inspection also revealed that your Dynabolt™ and Silverbolt Dynamic Stabilization Systems are misbranded under section 502(t)(2) of the Act, 21 USC 352(t)(2), in that your firm failed or refused to furnish material or information respecting these devices that are required under section 519 of the Act, 21 USC 3601, and 21 CFR Part 803 – Medical Device Reporting ( henceforth “MDR” ) Regulation. Significant deviations include, but are not limited to:
Failure to report to FDA no later than thirty ( 30 ) calendar days after the day that you receive or otherwise become aware of information from any source, that reasonably suggests that a device that you market may have caused or contributed to a death or serious injury or has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a). For example:
a. Complaint (b)(4) was received by your firm on March 20, 2009. This complaint involved a Dynabolt™ rod being pulled loose from the L4 screw requiring a revision surgery. The date of this report is July 28, 2009, over four ( 4 ) months after your film became aware of this adverse event.
b. Complaint (b)(4) was received on April 29, 2009. A Silverbolt construct implanted on June 24, 2008 was explanted by another surgeon because the ball-end became detached from the screw. MDR report date is July 28, 2009 which is approximately three (3) months after your firm became aware of the MDR event.
We have reviewed your response letter dated March 26, 2010. Your letter states that you submitted the two (2) above referenced product experience reports on July 28, 2009, as medical device reports, under manufacturer report numbers (b)(4) and (b)(4). We checked our medical device report database and were unable to locate these reports. Please re-submit these two (2) reports using the MEDWATCH form, Form FDA 3500A. These reports may be mailed in the following manner.
If you mail these reports by regular mail, please use the following address:
U. S. Food and Drug Administration
Center for Devices and Radiological Health
Medical Device Reporting
P.O. Box 3002
Rockville, Maryland 20847 – 3002
If you mail these reports by carrier service, please use the following address:
U. S. Food and Drug Administration
Center for Devices and Radiological Health
Medical Device Reporting
16071 Industrial Drive; Room #258
Gaithersburg, Maryland 20877 – 1462
Please submit a written response to this letter within fifteen ( 15 ) working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials for the Dynabolt™ device the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to:
Matthew Krueger
U. S. Food and Drug Administration
WO-66; Room #3676
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
and
Blake Bevill
Director of Compliance Branch
U. S. Food and Drug Administration
19701 Fairchild
Irvine, California 92612-2506
We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your’ responsibility to ensure that your promotional materials for Dynabolt™ comply with each applicable requirement of the Act and FDA implementing regulations.
Quality System
While some nonconforming practices or conditions were observed during the inspection, they do not appear to warrant consideration of regulatory follow-up at this time. These problems were reported to you and formally discussed with the firm’s management. Along with the Establishment Inspection Report ( henceforth “EIR” ) and the FDA form 483, the Office of Compliance has received your response dated March 26, 2010. Your response was received more than fifteen ( 15 ) days after the close of the inspection and so it was not reviewed.
The following is a listing of the FDA form 483 observations:
1. Failure to maintain an adequate record of the investigation by the formally designated unit to include any device identification(s) and control number(s) used, as required by 21 CFR 820.198(e)(3). For example, you did not follow your Product Experience Report (b)(4) and Complaint Investigation & Reporting (b)(4) procedures for a complaint event (b)(4) where a CT scan confirmed two broken (b)(4) Sl screws in a patient. Specifically, the part and lot numbers for the two broken screws were not documented, as required.
2. Failure to establish and maintain adequate procedures for reviewing, evaluating and investigating any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary, as required by 21 CFR 820.198(c). For example, you did not follow your Product Experience Report (b)(4) and Complaint Investigation & Reporting (b)(4) procedures for a complaint event (b)(4) where a CT scan confirmed two broken (b)(4) S1 screws in a patient. Specifically, e-mails dated November 3, 2008 indicate that the patient required a revision surgery and that the screws would be returned for evaluation, but the firm closed the complaint on November 4, 2008 without patient follow-up or evaluation of the screws, as required.
3. Failure to establish and maintain adequate procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, Document Review Request Number (b)(4), shows you approved and implemented an increase to the laser weld penetration specification from (b)(4) to (b)(4) for Dynabolt™ rods on December 12, 2008, as shown on drawing number (b)(4) This approval was made prior to the completion of the corresponding (b)(4) Test Report, (b)(4)which was completed on January 7, 2009, and approved on January 20, 2009.
4. Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). For example, Test Protocol: (b)(4) did not contain any approval signatures.
5. Failure to establish and maintain adequate procedures for quality audits and to conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example, six ( 6 ) of (b)(4) processes required to be audited per your Quality System Audit Schedule – 2009, were not audited. These processes include: Production/Outsourcing ( December ), Internal Audits ( May), Customer Complaints ( September ), CAPA ( March ), and Facilities Equipment ( November).
All of the connections to these observations will be verified at the next routinely scheduled inspection.
Sincerely,
/S/
Alonza Cruse
Director
Los Angeles District Office
cc: State of California
Department of Public Health / Food and Drug Branch
1500 Capital Avenue; MS -7602
P. O. Box #997413
Sacramento, CA 95899-7413
