BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST360 SPINAL FIXATION SYSTEM

    MDR report key: 839540 · Received February 27, 2007

    Report

    Report Number
    2184052-2007-00002
    Event Type
    Malfunction
    Date Received
    February 27, 2007
    Date of Event
    April 11, 2006
    Report Date
    January 17, 2007
    Manufacturer
    ZIMMER SPINE
    Product Code
    MCV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT #P041364; MANUFACTURE DATE 08/2004. EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS, FOR BOTH LOT NUMBERS REPORTED (P040857 AND P041364), DID NOT REVEAL ANY DISCREPANCIES. THE DEVICES WERE MANUFACTURED TO ALL PRINT SPECIFICATIONS. THESE DEVICES REMAIN IN THE PATIENT; NOT RETURNED FOR EVALUATION. (OTHER): REVIEW OF COMPLAINT TRENDING FOR THE PAST 36 MONTHS DID NOT REVEAL ANY FIELD REPORTS FOR THESE LOT NUMBERS. ONE FIELD REPORT WAS RECEIVED 19-MAY-06, FOR 07.00319.025, BUT THE LOT NUMBER WAS UNK. THE ST360 SPINAL FIXATION SYSTEM IFU (07.00514.001 REV G) STATES "INTENDED TO BE USED WITH BONE GRAFT WHICH IS REQUIRED TO PROVIDE ADDITIONAL SPINAL SUPPORT". IN ADDITION, "IN THE EVENT THAT BONE LOOSENING, DISASSEMBLING, AND/OR BREAKAGE OF THE IMPLANTS WILL EVENTUALLY OCCUR".

    Description of Event or Problem · 1

    PATIENT CONDITION PRIOR TO SURGERY DESCRIBED AS UNSTABLE AT THE L4/5 LEVEL, PAIN AT RIGHT THIGH, DISC HERNIATION AT L5/S1, FACET HYPERTROPHY L4/5. ORIGINAL SURGERY DATE 2006. L4/5 AND S1. FOUR 5.1X55MM PEDICLE SCREWS AT L4/5, TWO 5.5X45MM PEDICLE SCREWS AT S1, TWO 5.5MM X 8CM CURVED RODS, SIX LOCKING NUTS AND SIX 12-15MM CONNECTORS AND TWO 15CC TUTOGEN CANCELLOUS CHIPS, BONE MARROW ASPIRATE AND HEALOS. BONE GRAFT WAS NOT USED AT THE L5/S1 LEVEL. AT THREE MONTHS FOLLOW UP, THE X-RAY REVEALED A BROKEN SCREW AT S1. THE SURGEON DID NOT PERFORM A REVISION SURGERY, BECAUSE THE PATIENT WAS NOT IN PAIN AND WAS DOING WELL. 23-FEB-07, REP REPORTED THAT 2ND S1 SCREW IS BROKEN. PATIENT DOING WELL. BROKEN SCREW IS NOT CAUSING PAIN AND NO REVISION HAS BEEN PERFORMED OR IS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST360 SPINAL FIXATION SYSTEM ST360 PEDICLE SCREW MCV ZIMMER SPINE 07.00319.025 P040857

    Patients

    Seq Age Sex Outcome Treatment
    1 *