BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW

    MDR report key: 16286 · Received September 15, 1994

    Report

    Report Number
    MW1003377
    Event Type
    Injury
    Date Received
    September 15, 1994
    Date of Event
    August 25, 1988
    Report Date
    September 4, 1994
    Manufacturer
    UNKNOWN
    Product Code
    MCV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    7/7/88, DEVICE INSERTED WITH SPINAL FUSION. L-4 HOOK DISENGAGED, 7/24/88. 8/25/88 INSERTION OF PEDICLE SCREW IN L-4 AND RE-INSTRUMENTATION. 8/20/91 REMOVAL OF DEVICE, PEDICLE SCREW AND REPAIR OF PSEUDARTHROSIS OF L-4. REVISION OF L-4 WITH INSERTION OF BONE GROWTH STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDICLE SCREW Implant PEDICLE SCREW MCV UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Disability