BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 2950118 · Received February 8, 2013

    Report

    Report Number
    1030489-2013-00420
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    February 22, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE SUPERIOR DYNAMIC JAW IS FRACTURED ON ONE SIDE AND BENT. THE LOCATION, DIRECTION AND AMOUNT OF FORCE REQUIRED IN ORDER TO BEND AND FRACTURE THE JAW IS CONSISTENT WITH APPLICATION OF ROTATIONAL OVERLOAD.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INSTRUMENT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE PITUITARY CRACKED DURING A TLIF SPINAL SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54171 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA GZ11E039

    Patients

    Seq Age Sex Outcome Treatment
    1