BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMBR WDG I/F CGE(9X11)X9X23

    MDR report key: 7552985 · Received May 30, 2018

    Report

    Report Number
    1526439-2018-50498
    Event Type
    Malfunction
    Date Received
    May 30, 2018
    Date of Event
    May 2, 2018
    Report Date
    May 2, 2018
    Manufacturer
    DEPUY SPINE INC
    Product Code
    MAX
    UDI-DI
    (01)UNKNOWN
    PMA / PMN Number
    P960025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). VISUAL EXAMINATION FOUND THAT THE CAGE HAD FRACTURED INTO MULTIPLE PIECES. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING. A DEFINITIVE ROOT CAUSE FOR THE LUMBAR WEDGE CAGE FRACTURING CANNOT BE POSITIVELY DETERMINED. HOWEVER, IT SHOULD BE NOTED THAT POLYMER/CARBON-FIBER CAGES ARE DESIGNED TO SUPPORT PHYSIOLOGIC LOADS. HIGHER THAN ANTICIPATED TORQUE LEVELS WHEN APPLIED TO INSERTION TOOLS, CAN CAUSE SPLITTING OR FRACTURE OF CAGES. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS WERE FOUND, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE PLIF SURGERY FOR DEGENERATIVE LUMBAR SPONDYLOLISTHESIS WAS PERFORMED USING THE JAGUAR SYSTEM. THE FIXED AREA WAS L3- L4. DURING THE SURGERY, THE SURGEON FORCIBLY INSERTED THE REPORTED IMPLANT (173123209) BECAUSE THE BONY SPUR WAS SEEN BEHIND THE VERTEBRAL BODY. AS A RESULT, THE REPORTED IMPLANT GOT BROKEN AT ITS FAR END. NO BROKEN PIECES WERE FOUND LEFT IN THE PATIENT¿S BODY, AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A LESS-THAN-30-MINUTE DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE SURGEON COMMENTS THAT THIS EVENT MIGHT BE CAUSED BY MUCH STRESS THAT WAS APPLIED TO THE FAR END OF THE REPORTED IMPLANT WHEN ADJUSTING THE INSERTION ANGLE WITH A HAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396743 LUMBR WDG I/F CGE(9X11)X9X23 INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX DEPUY SPINE INC K5564 (01)UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1