BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T25 STARDRIVE SHAFT F/MATRIX STANDARD

    MDR report key: 3041947 · Received April 8, 2013

    Report

    Report Number
    1719045-2013-10567
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 12, 2012
    Report Date
    March 29, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POSTERIOR FUSION, LEVEL T10 TO L2 THE SURGEON WAS USING THE MATRIX SIMPLE PERSUADER AND IT WAS NOT WORKING PROPERLY. THE HANDLES WERE EXTREMELY HARD TO SQUEEZE. THE SURGEON SELECTED ANOTHER AND RESUMED THE PROCEDURE. THE SURGEON WAS PERFORMING THE FINAL TIGHTENING AND A TOTAL OF THREE DRIVERS WERE STRIPPING, THE CAPS AND ALL THREE TIPS BROKE. THE CAPS DID NOT NEED TO BE REPLACED AND ALL THREE TIPS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEMS. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143146 T25 STARDRIVE SHAFT F/MATRIX STANDARD HXX SYNTHES MONUMENT 6610964

    Patients

    Seq Age Sex Outcome Treatment
    1