BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW ANCHORAGE Ø3.0MM / L16MM

    MDR report key: 3770817 · Received April 24, 2014

    Report

    Report Number
    0008031020-2014-00199
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K083447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    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

    IT WAS REPORTED THAT THE ANCHORAGE MTP PLATE LOCKING SCREW DID NOT LOCK AND CUT THROUGH THE PLATE. HAD TO SWAP OUT THE PLATE, CAUSED 10 MIN DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANCHORAGE MTP PLATE LOCKING SCREW DID NOT LOCK AND CUT THROUGH THE PLATE. HAD TO SWAP OUT THE PLATE, CAUSED 10 MIN DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248933 LOCKING SCREW ANCHORAGE Ø3.0MM / L16MM PLATE, FIXATION, BONE HRS STRYKER TRAUMA SELZACH F02299

    Patients

    Seq Age Sex Outcome Treatment
    1 Other