BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM CORT SCRW NONSTRL 26MM

    MDR report key: 1021331 · Received March 28, 2008

    Report

    Report Number
    1818910-2008-00853
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    DEPUY ACE S.A. ' R.L.
    Product Code
    HWC
    PMA / PMN Number
    K905048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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

    SCREW HEAD CAME OFF OF THE SCREW; THE HEAD WILL BE RETURNED. THE REMAINDER OF THE SCREW IS STILL IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM CORT SCRW NONSTRL 26MM 87HWC HWC DEPUY ACE S.A. ' R.L. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR