BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX40MM

    MDR report key: 2920365 · Received January 17, 2013

    Report

    Report Number
    1818910-2013-00792
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    October 29, 2010
    Report Date
    December 21, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    LPH
    PMA / PMN Number
    K983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS ACETABULAR LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25314 PINN CAN BONE SCREW 6.5MMX40MM SCREW LPH DEPUY RAYNHAM C39F34000

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Other