BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_OSTEOSYNTHESIS_PRODUCT

    MDR report key: 3904133 · Received July 1, 2014

    Report

    Report Number
    0008031020-2014-00292
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE THREE CANULATED SCREWS REMOVED AND A CONVERSION TO A TOTAL HIP. NO X-RAYS, OP NOTES, MEDICAL RECORDS AVAILABLE AS PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382167 UNKNOWN_OSTEOSYNTHESIS_PRODUCT IMPLANT HWC STRYKER TRAUMA SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention