BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX THREADED PERSUADER - STANDARD

    MDR report key: 1974640 · Received December 29, 2010

    Report

    Report Number
    1719045-2010-00381
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MNI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED NOR EXPLANTED. SYNTHES IS UNABLE TO PROVIDE THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER, A DEVICE HISTORY RECORD REVIEW CAN NOT BE REQUESTED.

    Description of Event or Problem · 1

    DURING A POSTERIOR FUSION, THE SURGEON WAS HAVING PROBLEMS WITH TWO PERSUADERS. THEY WERE BECOMING STUCK THE SCREW HEADS AND THE SURGEON ROCKED THE SCREW BACK AND FORTH TO REMOVE THE PERSUADERS. FURTHER ALONG IN THE PROCEDURE, THE SURGEON WENT TO INERT A LOCKING CAP AND THE SADDLE TO THE CAP FELL OFF. SURGEON DISCARDED THE SADDLE AND USED THE LOCKING CAP WITHOUT THE SADDLE. AFTER THE ROD WAS SEATED, SURGEON DISCOVERED THAT THREE POLYAXIAL SCREW HEADS CAME OFF THE SCREWS. SURGEON REMOVED THE THREE SCREWS AND REPLACED THEM COMPLETING THE PROCEDURE TWO HOURS LONGER THAN EXPECTED. THIS IS ONE OF SIX REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX THREADED PERSUADER - STANDARD THREADED PERSUADER MNI SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR SCREW