BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOMIZED CRANIOFACIAL (CCI), CUSTOMIZED SKULL IMPLANT (CSI)

    MDR report key: 18247466 · Received November 30, 2023

    Report

    Report Number
    MW5148646
    Event Type
    Injury
    Date Received
    November 30, 2023
    Date of Event
    November 2, 2023
    Report Date
    November 29, 2023
    Manufacturer
    KELYNIAM GLOBAL, INC.
    Product Code
    GWO
    UDI-DI
    00810125922640
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    KELYNIAM RECEIVED A REPORT FROM A DISTRIBUTOR / SALES REP THAT A PREVIOUSLY IMPLANTED MEDICAL DEVICE WAS TO BE REMOVED BECAUSE THE PT DEVELOPED AN INFECTION. KELYNIAM MANUFACTURES CUSTOM IMPLANTS BASED ON THE ORDER OF A PHYSICIAN AND ACCORDING TO A CT PROVIDED BY THE SURGEON. THE DESIGN OF THE IMPLANT IS PROVIDED TO THE SURGEON FOR DESIGN VERIFICATION BEFORE THE IMPLANT IS ACTUALLY PRODUCED. IF THE DESIGN IS ACCEPTABLE THE SURGEON SIGNS THE CASE ORDER FORM. KELYNIAM RECEIVED A REPORT THAT A PATIENT THAT WAS IMPLANTED IN (B)(6) OF 2023 HAD DEVELOPED AN INFECTION. A NEW DUPLICATE IMPLANT WAS REQUESTED. AN INTERNAL INVESTIGATION WAS INITIATED. THE INVESTIGATION INDICATED THAT THE DESIGN, AS APPROVED BY THE SURGEON WAS ACCURATE. THIS TYPE OF IMPLANT IS A CUSTOM DEVICE SOLD AS NON-STERILE AND IS SPECIFIC TO A SINGLE PATIENT ON THE ORDER OF A SINGLE SURGEON. KELYNIAM HAS ATTEMPTED TO CONTACT THE SURGEON AND WILL CONTINUE TO DO SO. IF ANY RELEVANT INFORMATION IS OBTAINED THIS REPORT WILL BE AMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73159 CUSTOMIZED CRANIOFACIAL (CCI), CUSTOMIZED SKULL IMPLANT (CSI) PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE GWO KELYNIAM GLOBAL, INC. PEEK-IM1004-TABS 00810125922640

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention