BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT - SCREW

    MDR report key: 1163119 · Received September 16, 2008

    Report

    Report Number
    9616680-2008-00284
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 24, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    HWC
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RESTORATION MODULAR FLUTED DISTAL STEM 17X267MM BOWED WAS IMPLANTED, AND THE PREVIOUSLY USED MT3 PROXIMAL BODY AND 36MM BODY WERE ATTACHED. THE SURGEON TIGHTENED THE SCREW WITH THE 5MM BOLT ATTACHED TO THE T-HANDLE AND THE HEAD OF THE SCREW BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT - SCREW IMPLANT HWC STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other