BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINN CAN BONE SCREW 6.5MMX35MM

    MDR report key: 1041231 · Received May 8, 2008

    Report

    Report Number
    1818910-2008-01434
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 10, 2008
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K983014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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

    THE SCREW BROKE DURING SURGERY. ONLY THE HEAD OF THE SCREW WAS RECOVERED, THE THREADED PORTION REMAINS IN THE PATIENT'S BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN CAN BONE SCREW 6.5MMX35MM 87 LPH LPH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA B2VCS4000

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR