BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTICAL BONE SCR 32MM

    MDR report key: 1022107 · Received March 25, 2008

    Report

    Report Number
    1818910-2008-00751
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Report Date
    February 24, 2008
    Manufacturer
    DEPUY ACE S.A. 'R.L.'
    Product Code
    HSB
    PMA / PMN Number
    K871539
    Removal / Correction Number
    NA
    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

    DURING SURGERY, THE SCREW WHICH WAS USED FOR THE SECOND DISTAL HOLE WAS BROKEN. THE DOCTOR LEFT THE BROKEN SCREW IN THE PT'S BODY AND COMPLETED THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTICAL BONE SCR 32MM 87HSB HSB DEPUY ACE S.A. 'R.L.' NA DCDBRN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA