BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES END PLATE SUPERIOR

    MDR report key: 970292 · Received December 19, 2007

    Report

    Report Number
    MW5004772
    Event Type
    Injury
    Date Received
    December 19, 2007
    Date of Event
    December 13, 2007
    Report Date
    December 17, 2007
    Manufacturer
    SYNTHES SPINE
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    POST-OP L-SPINE X-RAY REVEALED L-5 FRACTURE RESULTING IN NERVE DEFICIT TO LOWER EXTREMITIES, AND BACK PAIN. SURGICAL REMOVAL OF IMPLANTS WERE NECESSARY AND RE-INSTRUMENTATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES END PLATE SUPERIOR SYNTHES PRO DISC- L KWP SYNTHES SPINE 5345969
    2 NONE INFERIOR END PLATE KWP SYNTHES SPINE 5591582
    3 NONE POLYETHYLENE INLAY KWP SYNTHES SPINE 537226

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention