BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW ANCHORAGE Ø3.0MM / L16MM

    MDR report key: 3840157 · Received May 30, 2014

    Report

    Report Number
    0008031020-2014-00252
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 6, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K083447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    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

    WAS REPORTED THAT ANCHORAGE LOCKING SCREW DID NOT LOCK INTO THE PLATE DURING LAPIDUS PROCEDURE. IT WAS REPORTED THAT SCREWS WERE LEFT IN AS "BONE" SCREWS.

    Description of Event or Problem · 1

    WAS REPORTED THAT ANCHORAGE LOCKING SCREW DID NOT LOCK INTO THE PLATE DURING LAPIDUS PROCEDURE. IT WAS REPORTED THAT SCREWS WERE LEFT IN AS "BONE" SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319453 LOCKING SCREW ANCHORAGE Ø3.0MM / L16MM PLATE, FIXATION, BONE HRS STRYKER TRAUMA SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other