BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 2944085 · Received February 5, 2013

    Report

    Report Number
    1030489-2013-00375
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 7, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUALLY CONFIRMED THE INSTRUMENT HANDLE IS BROKEN AT THE BASE WHERE IT INTERFACES WITH THE SUPERIOR SHAFT. OPTICAL EXAMINATION OF THE FRACTURE REVEALS A FAIRLY TORTUOUS FRACTURE, WITH NO INDICATION OF FATIGUE, CROSS SECTIONAL RIVERLINES AND FRACTURE MORPHOLOGY CONSISTENT WITH BEND STRESS OVERLOAD. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISUSE DUE TO BEND STRESS OVERLOAD AS THE MECHANISM OF FAILURE.

    Additional Manufacturer Narrative · 1

    (B)(6). (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 PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE AND THE TIP OF THE PITUITARY BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49030 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA GZ11C048

    Patients

    Seq Age Sex Outcome Treatment
    1