BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNFIX MINI-OPEN IMPLANT COUPLING

    MDR report key: 2926047 · Received January 23, 2013

    Report

    Report Number
    1719045-2013-00177
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MAX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. NEMCOMED, PRESENTLY AVALIGN NEMCOMED, MANUFACTURED THE SYNFIX MINI-OPEN IMPLANT COUPLING, THE COUPLINGS WERE INSPECTED AND CONFORMED TO THE SYNTHES INSPECTION SHEET. THERE WERE NO COMPLAINT-RELATED ANOMALIES. THE THREADED SHAFT OF THE COUPLING IS FRACTURED WITH APPROXIMATELY 11.5MM REMAINING IN THE IMPLANT. THE FRACTURED PORTION WHICH REMAINS IN THE IMPLANT HAS DAMAGED THREADS AND THE REMAINING SHAFT IS DAMAGED AS WELL. IT IS PROTRUDING OUT OF THE IMPLANT OFF-AXIS. THE OFF-AXIS ORIENTATION OF THE BROKEN THREAD SHAFT INDICATES THAT COUPLING WAS CROSS THREADED. THE CROSS THREADING LEAD TO THE OVER TIGHTENING OF THE THREADED SHAFT. THE OVER TIGHTENING LEAD TO TORSIONAL STRESSES EXCEEDING THE STRENGTH OF THE OF THE WEAKEST POINT ON THE SHAFT WHICH IS 2MM IN DIAMETER. THE DAMAGED THREADS ARE MOST LIKELY DUE TO THE REMOVAL OF THE IMPLANT USING OR INSTRUMENTS.

    Description of Event or Problem · 1

    AS THE SURGEON WAS TRYING TO ATTACH THE MINI OPEN GUIDE DURING AN ALIF FUSION L5 TO S1 WITH SYNFIX LR, THE INNER SPINDLE SNAPPED OFF IN THE IMPLANT AND REMAINED STUCK TO IT. THE ENTIRE IMPLANT WAS PULLED OUT AND A NEW IMPLANT INSERTED. SURGERY WAS PROLONGED 10 TO 15 MINUTES. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33060 SYNFIX MINI-OPEN IMPLANT COUPLING IMPLANT COUPLING MAX SYNTHES MONUMENT 80252

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SYNFIX-LR, IMPLANT COUPLING