BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_OSTEOSYNTHESIS_PRODUCT

    MDR report key: 3760745 · Received April 21, 2014

    Report

    Report Number
    0008031020-2014-00196
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 THE SURGEON CALLED THE SALES REP TO ADVISE HIM OF A PLATE BREAKAGE. THE PATIENT COMPLAINED OF PAIN AND DURING AN OFFICE VISIT, AN X-RAY REVEALED THAT THE PLATE WAS BROKEN. ADDITIONAL SURGERY HAS NOT BEEN SCHEDULED AND THE SALES REP DOES NOT HAVE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239980 UNKNOWN_OSTEOSYNTHESIS_PRODUCT IMPLANT HWC STRYKER TRAUMA SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention