BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLYAXL OPN SCRWDRVR- MODULAR TI MOD

    MDR report key: 1082600 · Received July 23, 2008

    Report

    Report Number
    1649384-2008-00390
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    May 26, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. EVALUATION IS PENDING.

    Description of Event or Problem · 1

    IN 2008, THE DISTRIBUTOR REPORTED THAT DURING SURGERY THE PRONG BROKE ON THE DRIVER. THE SURGEON WAS ABLE TO FINISH THE CASE WITH ANOTHER DRIVER IN THE KIT. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLYAXL OPN SCRWDRVR- MODULAR TI MOD INCOMPASS HXX ABBOTT SPINE, INC. 41XM

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK