BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTHESIS INSERTER

    MDR report key: 3931883 · Received July 14, 2014

    Report

    Report Number
    1030489-2014-03236
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    July 10, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MJO
    PMA / PMN Number
    P060023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT VISUAL REVIEW CONFIRMS IMPLANT INSERTER FOOT (PN# 6473610-03) IS BROKEN OFF FROM THE INSTRUMENT. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED A FAIRLY BRITTLE FRACTURE WITH RAYS EMANATING THROUGH THE CROSS-SECTIONAL AREA FROM THE AREA OF ORIGIN. OPTICAL EXAMINATION OF THE -03 FOOT COMPONENT IDENTIFIED SIGNIFICANT DEFORMATION AT THE POTENTIAL IMPACT POINTS DURING IMPLANTATION, AS WELL AS ON THE UNDERSIDE SURFACE WHICH MATES TO THE -01 HANDLE COMPONENT. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH OVERLOAD DUE TO IMPACT DURING ATTEMPTED IMPLANTATION.

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. "AFTER INSERTING THE DISC, THE SURGEON WANTED TO PUSH IT FEW MILLIMETERS FARTHER DOWN. DURING THIS PROCEDURE, THE BLACK PLASTIC PART OF THE IMPLANT INSERTER BROKE IN 2 PARTS". ALL OF THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410865 PROSTHESIS INSERTER PROSTHESIS, INTERVERTEBRAL DISC MJO MEDTRONIC SOFAMOR DANEK USA, INC EM11E0211

    Patients

    Seq Age Sex Outcome Treatment
    1