BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 3191565 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02557
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 29, 2013
    Report Date
    September 4, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL REVIEW AND OPTICAL OBSERVATION NOTED THE SUPERIOR DYNAMIC JAW IS BENT TO ONE SIDE. NO ADDITIONAL TIP CRACK, FRACTURE, OR BREAKAGE WAS IDENTIFIED. THE LOCATION, DIRECTION AND AMOUNT OF FORCE REQUIRED IN ORDER TO BEND THE JAW, IS CONSISTENT WITH LATERAL BEND STRESS OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE 2MM UPBITING MICROPITUITARY WAS BROKEN DURING USE IN SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290093 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA GZ11C051

    Patients

    Seq Age Sex Outcome Treatment
    1