BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.0MM CANN LOCKING FT 80MM

    MDR report key: 1930260 · Received November 24, 2010

    Report

    Report Number
    1818910-2010-09067
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    HRS
    PMA / PMN Number
    K060969
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    AN 8.0 POLYAX SCREW WENT THROUGH THE PLATE AND NEVER LOCKED INTO THE PLATE. WHEN TRYING TO BACK THE SCREW OUT IT STRIPPED. THIS CAUSED A 30-MINUTE SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8.0MM CANN LOCKING FT 80MM 87HRS HRS DEPUY ACE S.A. 'R.L. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR