BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5 CANCELLOUS BONE SCREW 35MM

    MDR report key: 2132571 · Received June 10, 2011

    Report

    Report Number
    2249697-2011-00867
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HWC
    PMA / PMN Number
    K894124
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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 MANUFACTURER. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFO BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR # 2249697-2011-00864, 00865 & 00866.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PT COMPLAINED OF PAIN X-RAY SHOWS BROKEN SCREWS AND VERTICAL CUP. CUP AND LINER AND SCREWS REMOVED. NEW CUP LINER AND SCREWS PLACED ALONG WITH HEAD EXCHANGE. CUP AND HEAD REVISION ONLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.5 CANCELLOUS BONE SCREW 35MM IMPLANT HWC STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other| R