BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2210062 · Received August 12, 2011

    Report

    Report Number
    1030489-2011-01046
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 13, 2011
    Report Date
    August 15, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    MAX
    PMA / PMN Number
    K073291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION OF THE INSTRUMENT CONFIRMS THE SUPERIOR TANG IS BROKEN OFF THE INSTRUMENT AND THE INFERIOR TANG IS BENT, CONSISTENT WITH BEND STRESS OVERLOAD. THE FRACTURE SURFACE REVEALS SIGNIFICANT DAMAGE TO THE FRACTURE SURFACE. THE TYPE AND LOCATION OF THE INSTRUMENT DAMAGE IS CONSISTENT WITH EXCESSIVE BENDING FORCE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS RECEIVED IN THE MANUFACTURER FOR EVALUATION. THE EVALUATION IS IN PROCESS. THE FOLLOW UP REPORT WILL BE SENT AFTER THE EVALUATION IS COMPLETED. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE CAGE INSERTER BROKE OFF IN PATIENT. THE BROKEN OFF PIECE WAS RETRIEVED. ALTHOUGH THE INSTRUMENT WAS USED IN SURGERY, NO PATIENT COMPLICATIONS WERE 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 MA05C009

    Patients

    Seq Age Sex Outcome Treatment
    1