BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOUNTAINEER M/L SCREW 3.5X22

    MDR report key: 2830360 · Received November 13, 2012

    Report

    Report Number
    1526439-2012-00270
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    April 22, 2013
    Report Date
    November 13, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    MNI
    PMA / PMN Number
    K041203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. A FOLLOW UP MEDWATCH REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. (B)(4): DEVICE REMAINS IN PATIENT.

    Additional Manufacturer Narrative · 1

    A SINGLE AXIAL CUT CT IMAGE AND 2 X-RAY IMAGES WERE PROVIDED TO DEPUY SYNTHES SPINE FOR REVIEW COMPLAINT (B)(4). THE IMPLANT WAS NOT REMOVED, NOT RETURNED. REVIEW OF THE DHR FOUND THE LOT MET SPECIFICATION REQUIREMENTS WHEN RELEASED TO STOCK. HAVING RECEIVED ONLY A SINGLE AXIAL CUT CT IMAGE, IT IS DIFFICULT TO FULLY ASSESS THE STATUS OF THE FUSION. HOWEVER, THE DESCRIBED EVENT AND IMAGE PROVIDED MAY SUGGEST NON-UNION. IN THE ABSENCE OF FURTHER IMAGING OR PATIENT RISK FACTORS, WE ARE UNABLE TO DRAW ANY FURTHER CONCLUSIONS REGARDING THE CAUSE OF THE FAILURE. AT THE TIME OF THE COMPLAINT, IT WAS REPORTED THAT THE PATIENT WAS ASYMPTOMATIC AND NO REVISION SURGERY WAS PLANNED. IF NEW INFORMATION BECOMES AVAILABLE CONCERNING THE PATIENT'S STATUS OR ADDITIONAL IMAGING IS PROVIDED, THE COMPLAINT FILE WILL BE REOPENED AND FURTHER REVIEWED.

    Description of Event or Problem · 1

    CONTACT REPORTS O-C2 INSTRUMENTATION WAS PERFORMED FOR DISLOCATION OF C1 USING THE MOUNTAINEER SYSTEM. EXAMINATION OF POST-OP X-RAYS FOUND BREAKAGE OF THE SCREW. THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE CONSEQUENCES AND REVISION SURGERY HAS NOT BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOUNTAINEER M/L SCREW 3.5X22 ORTHOSIS, SPINAL PEDICLE FIXATION MNI DEPUY RAYNHAM AMJDT5

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention