BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINELINK

    MDR report key: 381488 · Received March 7, 2002

    Report

    Report Number
    2242816-2002-00003
    Event Type
    Malfunction
    Date Received
    March 7, 2002
    Report Date
    February 27, 2002
    Manufacturer
    EBI, L.P.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MD NOTED ON X-RAY THE COUPLERS HAD LOST FIXATION TO THE ROD. PATIENT HAD ALREADY FUSED. MD REMOVED FIXATION AS PREVIOUSLY PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINELINK INTERNAL FIXATION KWQ EBI, L.P. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other