BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST360

    MDR report key: 1512705 · Received October 16, 2009

    Report

    Report Number
    2184052-2009-00075
    Event Type
    Malfunction
    Date Received
    October 16, 2009
    Date of Event
    September 10, 2009
    Report Date
    September 15, 2009
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETAINED BY THE HOSPITAL AND NOT AVAILABLE FOR EVAL. DEVICE LOT NUMBER IS UNK. DEVICE 2: MODEL # 07.00295.001, CATALOG# 07.00295.001.

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED TO REMOVE MINI CONNECTORS AFTER BEING REPORTED THAT THE PT HAD FALLEN. ON X-RAY IT APPEARED THAT 2 LATERAL CONNECTORS WERE OFF THE ROD. THE CONNECTORS WERE RETIGHTENED ON THE ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST360 ST360 10-12MM STRAIGHT CONNECTOR KWQ ZIMMER SPINE, INC. 07.00295.004 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R