BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 7693326 · Received July 17, 2018

    Report

    Report Number
    1030489-2018-01011
    Event Type
    Injury
    Date Received
    July 17, 2018
    Date of Event
    May 24, 2018
    Report Date
    October 25, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    X-RAY REVIEW RESULT: POST-OP AND POST FUSION CT/X-RAY PROVIDED FOR C5-6 ARTIFICIAL DISC REPLACEMENT AND REVISION TO ACDF PROVIDED. DISC IS TRANSLATED ANTERIORLY FOR THE DISC SPACE. THE CT SHOWS A IRREGULAR CONTOUR OF INTERVERTEBRAL SPACE AND THE GRAFT APPEARS TO BE OVERSIZED ALTHOUGH IN ITS EXTENDED STATE IT IS DIFFICULT TO TELL, SUSPECT A COMBINATION OF SURGICAL TECHNIQUE AND PATIENT HAD LED TO THIS HARDWARE FAILURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG #6470315, PMA #P060023 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE R EPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED: DUE TO IMDRF HARMONIZATION, SOME PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. PRODUCT ANALYSIS RESULT: VISUAL MICROSCOPIC THERE ARE MULTIPLE CUTS IN THE SHEATHING OF THE DISC. THERE IS ONE LARGE TEAR THAT IS CONSISTENT WITH AT INSTRUMENT GRABBING THE DISC TO REMOVE THE IMPLANT. THE OTHER CUTS COULD HAVE BEEN THE RESULT OF MOVEMENT INSIDE THE DISC SPACE. IF PRESSURE WAS LOST INSIDE THE BRYAN DISC IT COULD MOVE. 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 INDIKATION RITZOPATY/CERVICAL FUSION AT C5-C6 DUE TO SOME UNKNOWN REASONS. POST-OP, THE IMPLANT HAD PULLED OUT. PATIENT CAME FOR CHECKUP ON (B)(6) AND WAS FEELING WELL BUT THE DOCTOR ORDERED X-RAY WHICH A STANDARD PROTOCOL. THERE HE COULD SEE THAT THE IMPLANT HAD PROTRUDED. ONE WEEK LATER SHE CAME BACK EXPERIENCING SQUEEKING SOUNDS. DECISION WAS MADE TO REMOVE THE IMPLANT AND DO A REVISION SURGERY WITH CAGE AND PLATE INSTEAD. DURING SURGICAL EXPOSURE FOR REMOVAL WE COULD ALSO SEE THAT THE IMPLANT HAD ROTATED FROM THE ORIGINAL POSITION AT 12 O'CLOCK. DURING EXPLANTATION THE PLYURETHANE SHEATH WAS PERFORATED ON ONE SIDE. WE COULD SEE TWO TEARS BUT ITS VERY UNCERTAIN THAT THE SECOND TEAR HAPPENED DURING EXPLANTATION. IN DISCUSSION WITH THE DOCTORS THEY ARE CONVINCED THAT IT WAS ONLY ON ONE SIDE THAT THEY TEARED. IN THE NEUCLEUS ONE CAN SEE THAT THERE IS EITHER METALLOSIS OR OTHER RESIDUE/BLACK MATTER WHICH THEY SUSPECT CAN BE DUE TO TEAR IN THE IMPLANT AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538141 BRYAN CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA 0454490W

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention