BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC C US IMPLANT

    MDR report key: 11752266 · Received April 30, 2021

    Report

    Report Number
    3007494564-2021-00025
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    March 17, 2021
    Report Date
    April 26, 2021
    Manufacturer
    CENTINEL SPINE, LLC.
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT RECEIVED A PRODISC C US IMPLANT ON AN UNKNOWN DATE. THE PATIENT WAS DIAGNOSED FOR A REMOVAL PROCEDURE AND CONVERSION TO ACDF AROUND (B)(6) 2021. THE REMOVAL PROCEDURE WAS SCHEDULED FOR (B)(6) 2021, BUT THIS CASE WAS CANCELLED ON (B)(6) 2021 WITH NO RESCHEDULED DATE. THE REASON FOR THE CANCELLATION IS UNKNOWN. THE REASON FOR THE SURGICAL INTERVENTION IS UNKNOWN WITH NO INDICATION FROM THE SURGEON. THERE HAS BEEN NO INDICATIONS OF PATIENT COMPLICATIONS OR SYMPTOMS. PATIENT IMAGING WAS PROVIDED SHOWING THE PRODISC C DEVICE IS POSITIONED ANTERIOR OF THE VERTEBRAL MIDLINE IN A LATERAL VIEW. THIS LED TO A CONSERVATIVE ASSUMPTION THAT SURGICAL INTERVENTION WOULD BE RESCHEDULED AT A LATER DATE TO PREVENT SERIOUS INJURY. THE PRODISC C FACE AND ANTERIOR KEEL APPEAR EVEN WITH THE ANTERIOR FACE OF THE DISC SPACE. IT IS UNKNOWN IF THIS WAS THE ORIGINAL POSITIONING AT IMPLANTATION OR THE DEVICE MIGRATED POST OPERATIVELY TO THIS POSITION. DHR REVIEW COULD NOT BE COMPLETED AS PART AND LOT NUMBERS WERE NOT PROVIDED AND COULD NOT BE TRACED. COMPLAINT TRENDING DETERMINED THE RATE OF COMPLAINTS WAS WITHIN ACCEPTABLE LIMITS. ASSOCIATED RISKS WERE IDENTIFIED IN THE PRODISC C US DESIGN FMEA. NO DEVICE WAS RETURNED FOR EVALUATION. AT THE TIME OF THIS SUBMISSION THE DEVICE REMAINS IMPLANTED IN THE PATIENT. DUE TO THE TIME DELAY BETWEEN THE DATE OF AWARENESS AND THE SCHEDULED PROCEDURE, THIS MDR MUST BE SUBMITTED PRIOR TO COMPLETION OF THE SURGICAL INTERVENTION. A FOLLOW UP SUBMISSION WILL BE COMPLETED IF THE REMOVAL PROCEDURE GOES AHEAD AS SCHEDULED. THIS IS SUBMISSION 1 OF 1 FOR 1 OF 1 DEVICES INVOLVED.

    Description of Event or Problem · 1

    A PATIENT WITH A PRODISC C US IMPLANT HAS BEEN DIAGNOSED AND SCHEDULED FOR A REMOVAL/EXPLANTATION PROCEDURE ON (B)(6) 2021. THE SCHEDULED REMOVAL WAS CANCELLED AND NOT PERFORMED. THERE HAS BEEN NO RESCHEDULE DATE PROVIDED. THE PATIENT WAS DIAGNOSED WITH AN UNKNOWN CONDITION REQUIRING SURGICAL INTERVENTION AROUND (B)(6) 2021. THE EXACT DATE IS UNKNOWN. THE PATIENT IMAGING TAKEN ON AN UNKNOWN DATE SHOWS THE IMPLANT POSITIONED AT THE ANTERIOR FACE OF THE DISC SPACE. THIS POSITIONING IS MOST LIKELY THE REASON FOR SURGICAL INTERVENTION; HOWEVER, NO SPECIFIC REASON FOR THE SCHEDULED REMOVAL HAS BEEN PROVIDED. THE POSITIONING MAY BE FROM INITIAL IMPLANTATION OR THE RESULT OF DEVICE MIGRATION POST OPERATIVELY. PATIENT COMPLICATIONS AND/OR SYMPTOMS HAVE NOT BEEN INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653530 PRODISC C US IMPLANT PROSTHESIS, INTERVERTEBRAL DISC MJO CENTINEL SPINE, LLC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention