BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERVICAL ALLOGRAFT

    MDR report key: 5442793 · Received February 17, 2016

    Report

    Report Number
    3008524126-2016-00005
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Date of Event
    January 19, 2016
    Report Date
    February 12, 2016
    Manufacturer
    ORTHOFIX INC
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. AFTER COMPRESSING AND RELEASING THE (90-0664) TOP AND (90-0663) SPRING, THE FORK DOES NOT RETURN TO ITS ORIGINAL RESTING POSITION. IT REMAINS IN A SLIGHTLY OPEN POSITION. THIS NEGATIVELY AFFECTS THE INSERTER'S ABILITY TO HOLD THE ALLOGRAFT. THE SOURCE OF THE COMPLAINT RESIDES WITH THE (90-0663) SPRING. RUST, DEBRIS AND FATIGUE CAN AFFECT THE SPRING'S RESTORING FORCE AND CAUSE IT TO REMAIN OPEN AND THEREFORE NOT FULLY HOLD THE ALLOGRAFT. IMPACTION AND RESIDUAL USE CAN DEFORM THE FORK AS WELL.

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THAT DURING AN ACDF CASE THE INSERTER DID NOT ENGAGE THE ALLOQUENT PROPERLY RESULTING IN A DELAY IN THE CASE. SURGEON USED THE INSERTER WITH THE ASSISTANCE OF ANOTHER INSTRUMENT TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99416 CERVICAL ALLOGRAFT ALLOGRAFT INSERTER MAX ORTHOFIX INC 30-1020 29023-MB08

    Patients

    Seq Age Sex Outcome Treatment
    1