BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5 CANCELLOUS BONE SCREW 25MM

    MDR report key: 2090534 · Received April 19, 2011

    Report

    Report Number
    2249697-2011-00530
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HWC
    PMA / PMN Number
    K894124
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "ACETABULAR SCREW BROKE DURING IMPLANTATION. SCREW WAS EXTRACTED, NO SUBSTITUTE WAS USED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.5 CANCELLOUS BONE SCREW 25MM IMPLANT HWC STRYKER ORTHOPAEDICS MAHWAH NA MHDHX9

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention