BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 6731068 · Received July 21, 2017

    Report

    Report Number
    1030489-2017-01804
    Event Type
    Injury
    Date Received
    July 21, 2017
    Date of Event
    June 23, 2017
    Report Date
    September 21, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. (B)(4). 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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    NO SPECIFIC NON-CONFORMANCE REGARDING RETURNED IMPLANT. VISUAL REVIEW IDENTIFIED EXPLANTED BRYAN DISC, WITHOUT EVIDENCE OF BONY INGROWTH ON BOTH ENDPLATES, LIKELY DUE TO VERY LIMITED TIME IN VIVO. DAMAGE AND OF RETURNED IMPLANT CONSISTENT WITH EXPLANTATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL SURGERY IN WHICH THE PROSTHESIS WAS IMPLANTED IN THE CERVICAL. POST-OP, THE PATIENT COLLAPSED AND EXPERIENCED HYPER EXTENSION OF HER NECK FOLLOWED BY PAIN AND DISCOMFORT. PATIENT UNDERWENT A REVISION SURGERY IN WHICH DEVICE REMOVAL HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512913 BRYAN CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA 0297679W

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| R