BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGER SHARK TL

    MDR report key: 15112456 · Received July 27, 2022

    Report

    Report Number
    3005819474-2022-00001
    Event Type
    Malfunction
    Date Received
    July 27, 2022
    Date of Event
    June 23, 2022
    Report Date
    July 22, 2022
    Manufacturer
    CHOICE SPINE LLC
    Product Code
    MAX
    PMA / PMN Number
    K172816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT HAD LEG PAIN. IMPLANT REMOVED ON (B)(6) 2022. THE TIGERSHARK THREADED TL IMPLANT IS DESIGNED WITH A POROUS STRUCTURE ON THE SUPERIOR AND INFERIOR FACES. THIS POROUS STRUCTURE CREATES A ROUGHENED SURFACE THROUGH THE ADDITIVE MANUFACTURING PROCESS. WHEN THE CORRECT SIZE IMPLANT IS USED, THE ROUGHENED SURFACES OF THE IMPLANT WILL INTERACT FRICTIONALLY WITH THE VERTEBRAL BODIES PREVENTING MIGRATION. IN THIS INSTANCE IT SEEMS THAT SURGEON USED A SMALLER IMPLANT THAN WHAT WAS MOST LIKELY NEEDED FOR THE DISC SPACE.

    Description of Event or Problem · 0

    L4-L5 CAGE MIGRATION AND REQUIRED REOPERATION AND REMOVE AND REPLACE CAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944582 TIGER SHARK TL TIGER SAHRK TL MAX CHOICE SPINE LLC 9572-110

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention