BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST360 SPINAL FIXTION SYSTEM

    MDR report key: 811429 · Received December 29, 2006

    Report

    Report Number
    2184052-2006-00013
    Event Type
    Malfunction
    Date Received
    December 29, 2006
    Date of Event
    December 1, 2006
    Report Date
    December 1, 2006
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    MCV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ST360 SPINAL FIXATION SYSTEM IFU (07.00514.001 REV F) STATES "INTENDED TO BE USED WITH BONE GRAFT WHICH IS REQUIRED TO PROVIDE ADDITIONAL SPINAL SUPPORT". IN ADDITION, "IN THE EVENT THAT BONE IS NOT PROVIDED TO FACILITATE FUSION, BENDING, LOOSENING, DISASSEMBLING, AND/OR BREAKAGE OF THE IMPLANTS WILL EVENTUALLY OCCUR.

    Description of Event or Problem · 1

    ORIGINAL SURGERY DATE IN 2006. ST360 CONSTRUCT IMPLANTED FROM L3 TO L5. NO INTERBODY DEVICES WERE USED IN THIS CASE. REVISION SURGERY DATE WAS SIX MONTHS LATER. TO EXTEND CONSTRUCT TO S1 DUE TO PT LEG PAIN. NO INTERBODY DEVICE WAS USED IN THIS CASE. DURING THE REVISION SURGERY, IT WAS IDENTIFIED THAT ONE SCREW, AT L5 LEFT SIDE, WAS LOOSE IN THE PEDICLE. IT IS UNKNOWN IF THE PT WAS IN AN ACCIDENT OR FELL, THAT WOULD HAVE CAUSED THE SCREW TO BECOME LOOSE. THE L5 SCREW, LEFT SIDE, WAS REMOVED AND NO NEW SCREW WAS INSERTED. TWO SCREWS WERE INSERTED AT S1, LEFT AND RIGHT SIDE. CONNECTORS, RODS AND LOCKING NUTS WERE ATTACHED AND THE CASE WAS COMPLETED. THE SCREW WAS NOT RETURNED FOR ANALYSIS; THE REP STATED THAT THE SCREW WAS DISPOSED OF DURING SURGERY AT THE HOSP. SEE SECTION H10 FOR LOT NUMBER DESCRIPTION. THE SALES ORDER FOR ORIGINAL SURGERY WAS OBTAINED AND LISTED THE FOLLOWING SCREW PART/LOT #'S: 07.00319.035 (6.5X45MM) LOT # P051038 AND P050822 44 - P051038 MFG DATE NOV-05, P050922 MFG DATE AUG-05, 07.00319.034 (6.5X40MM) LOT NUMBER P050821, 07.00319.9024 (5.5X40MM) LOT NUMBER P051035. TYPICALLY, LARGER SCREWS ARE INSERTED IN THE LOWER LUMBAR REGIONS. FOUR 6.5X45MM SCREWS WERE USED IN THE CASE AND MOST LIKELY INSERTED AT L4 AND L5. INSPECTION RECORDS FOR 6.5X45MM SCREWS REVEAL THESE SCREW COMPONENT LOTS PASSED QC INSPECTION. THE DEVICES WERE MANUFACTURED TO THE SPECIFICATIONS LISTED ON THE DRAWING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST360 SPINAL FIXTION SYSTEM PEDICLE SCREW MCV ZIMMER SPINE, INC. 07.00319.035 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other