Kelyniam Global, Inc. FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

During an inspection of your firm located in Canton, Connecticut on May 10, 2017 through May 30, 2017, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures patient-specific cranial implants and maxillofacial implants. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

7.    Failure to establish corrective and preventive actions procedures, pursuant to 21 CFR 820.100(a).

Specifically, your firm made significant design changes to these devices, and did not submit a 510(k). For example, your firm modified the Integrated Fixation System. The performance of bone screws (e.g., maximum screw torque, screw retention strength) used to attach the Kelyniam Custom Skull Implant (CSI) to the native bone with(b)(4)is affected by bone screw and bone plate design features. The change from CSI fixation using bone plates and bone screws to CSI with Integrated Fixation System fixation using(b)(4)is an operating principle change which leads to the submission of a 510(k). Additionally, the Kelyniam Custom Skull Implant (CSI) is provided with 0.125” diameter pressure relief holes, equally spaced over the contour of the implant with 0.625” centerline spacing and a minimum of 0.

Potential Health Risks

Medical Devices and Radiological Health, Division 1 East1 Montvale AveStoneham, MA 02180

b.  Complaint investigations do not require evaluating if there was a related injury, death, infection, or extension in surgery. The Medical Device Reporting Form, QF-85-01-1, is also not being used to evaluate complaints. Examples of complaints in which the form was not completed includes: Intake Request 1408 (for implant fit problems); Intake Request 1416 (for implant fit problems); and Intake Request 1452 (for some perfusion holes missing and placed incorrectly).

Regulatory Context

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received a response from Dr. Mark V. Smith, Director, dated June 20, 2017, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations.These violations include, but are not limited to, the following:

1.    Failure to establish and maintain design change procedures, pursuant to 21 CFR 820.30(i). For example, your firm failed to perform design validation for the following significant design changes: