BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX35MM

    MDR report key: 1984534 · Received January 28, 2011

    Report

    Report Number
    1818910-2011-01202
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NDJ
    PMA / PMN Number
    K983014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    PATIENT REVISED FOR LOOSENING AND MALPOSITIONED CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN CAN BONE SCREW 6.5MMX35MM 87 NDJ, LPH NDJ DEPUY ORTHOPAEDICS, INC. NA AN5K24000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention NA.