BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYAN CERVICAL DISC SYSTEM

    MDR report key: 7246955 · Received February 7, 2018

    Report

    Report Number
    1030489-2018-00176
    Event Type
    Injury
    Date Received
    February 7, 2018
    Date of Event
    February 1, 2017
    Report Date
    July 25, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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 (B)(4) WAS CLEARED IN THE UNITED STATES. EVENT DATE: (B)(6) 2017 (DATE UNKNOWN). IMPLANT DATE: (B)(6) 2012 (DATE AND MONTH ARE UNKNOWN). 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: X-RAY REVIEW RESULT: A SINGLE POST-OP X-RAY IS PROVIDED WHICH IS AN AP VIEW. LEVEL IS UNKNOWN. THE IMPLANT IS SEEMED TO BE PLACED OFF OF MIDLINE AND IS OUT OF ALIGNMENT BY REPORT THE PATIENT SUFFERED A FALL. IT IS UNKNOWN IF THE APPEARANCE OF THE GRAFT AND IF THE REPORTED SYMPTOMS ARE 2 DEGREE FAR FROM THE ADJACENT LEVEL DISEASE. 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 AN UNSPECIFIED SPINAL SURGERY FOR THE IMPLANTATION OF CERVICAL DISC DUE TO DISC PROLAPSE. POST-OP, THE PATIENT FAINTED AND FELL ON THE GROUND. AFTER THE FALL, PATIENT HAD PAIN IN HER HANDS AND A NUMBNESS. THE NUCLEUS INSIDE THE PROSTHESIS WAS DISLOCATED. PATIENT UNDERWENT REVISION SURGERY FOR THE REPLACEMENT OF THE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91848 BRYAN CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other| R