BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI CLAMP FOR USS ILIAC

    MDR report key: 1861306 · Received October 4, 2010

    Report

    Report Number
    1719045-2010-00281
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    HBL
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    INFO NOT PROVIDED ON INITIAL REPORT. ADD'L INFO HAS BEEN REQUESTED. DEVICE WAS IMPLANTED AND EXPLANTED DURING THE SAME SURGERY. MANUFACTURE DATE WILL BE DETERMINED AS PART OF A DEVICE HISTORY RECORD REVIEW. INVESTIGATION NOT COMPLETE, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PT UNDERWENT A REVISION OF L1-L5 INSTRUMENTATION TO EXTEND THE CONSTRUCT TO THE ILIUM. SURGEON COULD NOT GET THE CONNECTOR TO SLIDE OVER THE ILIAC COLLETT SO THAT THE NUT COULD BE TIGHTENED. THE HOLDING SLEEVE OF THE ROD CLAMP BROKE OFF WHERE IT THREADS INTO THE CLAMP (ALL PIECES WERE RETRIEVED). A SECOND HOLDING SLEEVE AND ROD BROKE IN THE SAME MANNER. SURGEON HAD TO MANUALLY THREAD A STEIMAN PIN INTO THE ROD CONNECTOR TO COMPLETE THE PROCEDURE. THE TOTAL TIME ADDED TO THE PROCEDURE DUE TO THIS ISSUE, AND THE FAILURE OF THE ROD CLAMP "STICKS" WAS 45 MIN -1 HOUR. THE PROCEDURE WAS COMPLETED, AND THE PT SUFFERED NO ILL EFFECTS. THIS IS THREE OF FOUR REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI CLAMP FOR USS ILIAC CLAMP HBL SYNTHES (USA) NA 3022469

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR