BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 4962961 · Received August 4, 2015

    Report

    Report Number
    1030489-2015-01891
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 8, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HRX
    PMA / PMN Number
    K002931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    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 INTRA-OP, THE IMAGE FROM THE METRX WAS "FOGGY" AT THE BEGINNING OF THE SURGERY. SURGEON COMPLAINED THAT HE EXPERIENCED "TOO MANY PRODUCT PROBLEMS". THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE PATIENT COMPLICATIONS WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510984 N/A ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK USA, INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1