BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANCELLOUS BONE SCREW 6.5X30MM

    MDR report key: 1021298 · Received March 27, 2008

    Report

    Report Number
    1818910-2008-00963
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 28, 2008
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    HWC
    PMA / PMN Number
    K970929
    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

    DURING SURGERY, ACETABULUM FRACTURE OCCURRED, WHEN THE DOCTOR TRIED TO INSERT THE LINER. TIME OF THE SURGERY WAS EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANCELLOUS BONE SCREW 6.5X30MM 87HWC HWC DEPUY INTERNATIONAL, LTD. NA YR9ERH4000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention