BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 4140719 · Received October 3, 2014

    Report

    Report Number
    1030489-2014-03812
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    August 29, 2014
    Report Date
    October 20, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    MAX
    PMA / PMN Number
    K094025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (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: THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. OPTICAL EXAMINATION CONFIRMS THE IMPLANT IS FRACTURED INTO MULTIPLE PIECES AND BROKEN. SOME OF THE BROKEN OFF PIECES ARE MISSING AND NOT RETURNED FOR ANALYSIS. THE EXTENT OF THE DAMAGE, AS WELL AS THE AREA OF FRACTURE INITIATION AT THE INSERTER ATTACHMENT POINT SUGGESTS SIGNIFICANT FORCE WAS UTILIZED DURING THE ATTEMPTED INSERTION. OPTICAL EXAMINATION OF THE FRACTURE SURFACES IDENTIFIED MORPHOLOGY CONSISTENT WITH BRITTLE OVERLOAD DURING INSERTION AS THE MECHANISM OF FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TLIF SPINAL SURGERY THE CAGE WAS BROKEN WHILE BEING IMPACTED. IT WAS ALSO REPORTED THAT IT WAS SPECIFICALLY INTENDED TO BE IMPLANTED FROM THE LEFT SIDE OF L5-S1 LEVEL. NO FRAGMENT OF THE IMPLANT WAS REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619831 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H11J1422

    Patients

    Seq Age Sex Outcome Treatment
    1