BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTICAL BONE SCR

    MDR report key: 1772320 · Received July 23, 2010

    Report

    Report Number
    1818910-2010-04810
    Event Type
    Injury
    Date Received
    July 23, 2010
    Report Date
    June 24, 2010
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    HWC
    PMA / PMN Number
    NA
    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

    THE PT WAS REVISED DUE TO SCREW BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTICAL BONE SCR TRAUMA DEVICE HWC DEPUY ACE S.A. 'R.L. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention