BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2112861 · Received June 3, 2011

    Report

    Report Number
    1030489-2011-00668
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 5, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    MAX
    PMA / PMN Number
    K073291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    MANUAL EVALUATION OF INSERTER SHAFT KNOB REVEALS KNOB OF MOVEMENT FROM SHAFT OF APPROXIMATELY APPROXIMATELY 1MM AS RECEIVED. KNOB WAS UNABLE TO BE REMOVED FROM SHAFT. MANUAL FUNCTIONAL CHECK WITH REVEALED NO ISSUES WITH PROPER TIGHTENING OF SAMPLE IMPLANT. HEX SET SCREW WAS NOT STRIPPED, AND ABLE TO BE TIGHTENED; AFTER TIGHTENING, SHAFT KNOB WAS UNABLE TO BE MOVED. UNABLE TO DETERMINE ROOT CAUSE OF EVENT WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TLIF SURGERY AT L5/S1, THE INNER SLEEVE OF THE CAGE INSERTER LOOSENED FROM THE LOCKING MECHANISM. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA DC09K163

    Patients

    Seq Age Sex Outcome Treatment
    1 CAGE