BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT INSERTER

    MDR report key: 4233620 · Received November 6, 2014

    Report

    Report Number
    1030489-2014-04262
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    February 24, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PRODUCT WAS RETURNED. VISUALLY AND DIMENSIONALLY CONFIRMED THE INSTRUMENT'S INNER SHAFT IS BROKEN AT THE BASE OF KNOB. THE FRACTURE APPEARS TO BE BOTH THROUGH THE CROSS-SECTION OF THE SHAFT, AND AT THE WELD, JOINING THE KNOB WITH THE INNER SHAFT. NO SURFACE DEFECT IDENTIFIED THAT COULD CONTRIBUTE TO CRACK PROPAGATION. DIMENSIONAL INSPECTION OF THE RELEVANT DIMENSIONS, FOUND TO BE WITHIN PRINT SPECIFICATION. MICROSCOPIC EXAMINATION OF THE FRACTURE'S SURFACE FINDS A FAIRLY BRITTLE FRACTURE WITH NO INDICATION OF TORSION OR FATIGUE, WITH RIVER LINES AND SHEAR LIPS, CONSISTENT WITH OVERLOAD. CONCLUSION: THE FRACTOGRAPHIC ANALYSIS OF THE FRACTURE SURFACE, IN CONJUNCTION WITH VERIFICATION OF CONFORMANCE TO THE RELEVANT DIMENSIONAL SPECIFICATION SUGGESTS FAILURE DUE TO OVERLOAD.

    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 A PATIENT UNDERWENT A PLIF AT L4-L5. AT THE TIME OF ENGAGING A CAGE WITH AN INSERTER, THE TIP OF THE INSERTER WAS BROKEN AS THE INSERTER WAS GIVEN A TWISTED MOVE. THE SURGERY WAS COMPLETED BY USING ANOTHER INSERTER AND CAGE. THE SURGICAL TIME WAS EXTENDED 16-30 MINUTES DUE TO THE INCIDENT. THE SURGEON SUSPECTED THAT THE "CENTER PART OF THE INSERTER MIGHT BE FATIGUED OR WEAK AS A STRUCTURE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714210 IMPLANT INSERTER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA PU13J001

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR IMPLANT| CAGE