BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 5969250 · Received September 22, 2016

    Report

    Report Number
    1030489-2016-02624
    Event Type
    Malfunction
    Date Received
    September 22, 2016
    Date of Event
    August 22, 2016
    Report Date
    August 14, 2018
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 2991022, 510K #K073291 WAS CLEARED IN THE UNITED STATES. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL AND OPTICAL EXAMINATION REVEALED THE IMPLANT IS BROKEN INTO MULTIPLE PIECES. NO EVALUATION CAN BE DONE IN THE IMPLANTS STATE. THERE ARE PARTS OF THE IMPLANT THAT ARE MISSING. ROOT CAUSE UNDETERMINED. DUE TO IMDRF HARMONIZATION, SOME PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY, FOR THE TREATMENT OF DEGENERATIVE DISC DISEASE. DURING SURGERY, WHILE INSERTING THE IMPLANT IT ADVANCED TOO FAR ANTERIOR DUE TO ANATOMY. THE DOCTOR THEN TRIED TO PULL THE IMPLANT BACK INTO POSITION, AT THAT TIME THE END OF THE IMPLANT BROKE AND CAME OUT WITH THE IMPLANT INSERTER. REPORTEDLY, THERE IS A GREAT DEAL OF THE IMPLANT THAT REMAINS INSITU. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620859 CAPSTONE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG NA H5261907

    Patients

    Seq Age Sex Outcome Treatment
    1