BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW ANCHORAGE Ø3.0MM / L16MM

    MDR report key: 3933763 · Received July 15, 2014

    Report

    Report Number
    0008031020-2014-00315
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 19, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K083447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. H3 OTHER TEXT : DEVICE WILL NOT BE RETURNED

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT WAS IDENTIFIED DURING PREVIOUS CASES THAT THE SCREW IS CONCOMITANT FOR THIS REPORTED FAILURE (SCREW WENT THROUGH THE PLATE). IF ANY OTHER INFORMATION IS PROVIDED INDICATING OTHERWISE, THE INVESTIGATION WILL BE REWORKED.

    Description of Event or Problem · 1

    THE PHARMACIST AT THE CLINIC, REPORTED THE FOLLOWING EVENT : "SCREWS NOT IMPLANTED BECAUSE THEY PASSED THROUGH THE PLATE."

    Description of Event or Problem · 1

    THE PHARMACIST AT THE CLINIC, REPORTED THE FOLLOWING EVENT : "SCREWS NOT IMPLANTED BECAUSE THEY PASSED THROUGH THE PLATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412393 LOCKING SCREW ANCHORAGE Ø3.0MM / L16MM PLATE, FIXATION, BONE HRS STRYKER TRAUMA SELZACH F02298

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other