BEUDAMED
    FDA Adverse Event Other Summary report: N

    ST360 SPINAL FIXATON SYSTEM

    MDR report key: 545288 · Received September 22, 2004

    Report

    Report Number
    2184052-2004-00016
    Event Type
    Other
    Date Received
    September 22, 2004
    Date of Event
    November 19, 2003
    Report Date
    September 22, 2004
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    MNI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ORIGINAL SURGERY OCCURRED IN 2003 TO IMPLANT TWO LUMBAR INTERBODY FUSION DEVICES ST L4/L5 AND L5/S1. TO FACILITATE STABILIZATION, A TWO LEVEL ST360 CONSTRUCT WAS IMPLANTED WHICH CONSISTED OF 6 SCREWS, 2 RODS, 6 ROD CONNECTORS AND 1 TRANSVERSE CONNECTOR. PT BEGAN COMPLAINING ABOUT PAIN (VERY MINIMAL) 2 MOS LATER. X-RAY IMAGES WERE TAKEN. PT RESUMED SMOKING 2 MOS LATER. PAIN LEVELS INCREASED AND SUBSEQUENTLY X-RAY IMAGES TAKEN 4 MOS LATER SHOW RIGHT SIDE, WAS BROKEN. IN JANUARY 2004 THE PT DESCRIBED NO PAIN, INSTEAD PT HAD STIFFNESS IN THE BACK. PT BEGAN TO COMPLAIN ABOUT PAIN AGAIN IN JUNE 2004. THE BROKEN SCREW HAS NOT BEEN REMOVED FROM PT AS OF THE DATE OF THIS REPORT. REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. SURGEON IS MONITORING THE PT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST360 SPINAL FIXATON SYSTEM ST360 PEDICLE SCREW MNI ZIMMER SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other