BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX15MM

    MDR report key: 1902066 · Received November 10, 2010

    Report

    Report Number
    1818910-2010-08012
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 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
    MD, 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

    PT WAS REVISED TO ADDRESS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN CAN BONE SCREW 6.5MMX15MM 87NDJ 87LPH NDJ DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA 427447

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention