BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW HOLDING CLASP FOR 6514-7-102

    MDR report key: 2161102 · Received June 17, 2011

    Report

    Report Number
    8010177-2011-00173
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    PER SALES REP, THE LUHR SCREWDRIVER HOLDING DEVICE SNAPPED OFF RESULTING IN THE ATTACHING SCREW TO BE LODGED. THEY CANNOT GET THE SCREW OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW HOLDING CLASP FOR 6514-7-102 INSTRUMENT LXH STRYKER OSTEOSYNTHESIS FREIBURG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK