BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM VA LOCKING SCREW STARDRIVE 26MM

    MDR report key: 2800362 · Received October 22, 2012

    Report

    Report Number
    1719045-2012-01099
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    COMPLAINT HISTORY AND NCR DATABASE WERE REVIEWED WITH NO COMPLAINT RELATED ANOMALIES NOTED. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING THE IMPLANTATION OF A VARIABLE ANGLE DISTAL RADIUS PLATE. WHEN THE SURGEON ATTEMPTED TO IMPLANT A VARIABLE LOCKING SCREW, THE SCREW WOULD NOT LOCK OR ENGAGE INTO THE PLATE, TURNING FREELY IN THE PLATE HOLE. THE SURGEON MADE SEVERAL ATTEMPTS TO BACK OUT THE SCREW, UNSUCCESSFULLY. THE VARIABLE LOCKING SCREW WAS ENGAGED INTO BONE BUT DID NOT ENGAGE IN THE SCREW THREADS WITHIN THE PLATE. THE SCREW WAS WOULD NOT LOCK INTO THE PLATE. THE SURGEON LEFT THE SCREW IMPLANTED. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.4MM VA LOCKING SCREW STARDRIVE 26MM LOCKING SCREW HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1