BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0 CANN. CANC. BONE SCREW

    MDR report key: 1004005 · Received February 26, 2008

    Report

    Report Number
    1818910-2008-00275
    Event Type
    Injury
    Date Received
    February 26, 2008
    Report Date
    January 27, 2008
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    HWC
    PMA / PMN Number
    K903810
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    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

    SURGERY WAS PERFORMED TO REMOVE THE BROKEN SCREW, HOWEVER, A PART OF THE BROKEN SCREW COULD NOT BE REMOVED AND REMAINED IN THE PT BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0 CANN. CANC. BONE SCREW 87HWC HWC DEPUY ACE S.A. 'R.L. NA DCPBKG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Required Intervention