BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC LAG SCREW 95MM

    MDR report key: 1903251 · Received November 12, 2010

    Report

    Report Number
    1818910-2010-08425
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    DEPUY ACE S.A. R. L.
    Product Code
    HSB
    PMA / PMN Number
    K042325
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 LOOSENING OF THE AR SCREW AND LAG SCREW MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC LAG SCREW 95MM 87HSB HSB DEPUY ACE S.A. R. L. NA J-DLBBYT

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention