BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_OSTEOSYNTHESIS_PRODUCT

    MDR report key: 3760734 · Received April 21, 2014

    Report

    Report Number
    0008031020-2014-00191
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RETURNED TO THE SURGEON FOR FOLLOW UP AND X-RAYS REVEALED THAT THE SCREWS WERE BROKEN. THE ORIGINAL PLATE WAS IMPLANTED WITH NEW SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240077 UNKNOWN_OSTEOSYNTHESIS_PRODUCT IMPLANT HWC STRYKER TRAUMA SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention