BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX40MM

    MDR report key: 1911682 · Received November 29, 2010

    Report

    Report Number
    1818910-2010-08819
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    NDJ
    PMA / PMN Number
    K983014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    PT REPORTS REVISION TO ADDRESS ACETABULAR LOOSENING. ADDITIONALLY, MEDICAL RECORDS RECEIVED ON (B)(6) 2010 INDICATE EVIDENCE OF METAL DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN CAN BONE SCREW 6.5MMX40MM 87NDJ, 87LPH NDJ DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA B28E94000

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention