BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC C US IMPLANT LARGE DEEP 5MM

    MDR report key: 12051409 · Received June 23, 2021

    Report

    Report Number
    3007494564-2021-00055
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    May 26, 2021
    Report Date
    June 21, 2021
    Manufacturer
    CENTINEL SPINE, LLC.
    Product Code
    MJO
    UDI-DI
    00843193112842
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY THE REPORTER INDICATES THE PRODISC C DEVICE WAS REMOVED DUE TO NECK PAIN AND RADICULOPATHY. IT WAS NOT KNOWN WHETHER THE PRODISC C DEVICE WAS CAUSING OR CONTRIBUTING TO THESE SYMPTOMS, SO A CONSERVATIVE ASSESSMENT DETERMINED THIS MAY BE A REPORTABLE ADVERSE EVENT REQUIRING AN MDR. THE REMOVAL WAS COMPLETED SUCCESSFULLY AND REPLACED WITH AN UNKNOWN DEVICE OR THERAPY. THE EXPLANTED DEVICES WERE RETRIEVED AND SENT FOR ANALYSIS AT A THIRD PARTY LABORATORY. DHR REVIEW DID NOT FIND ANY ISSUES DURING MANUFACTURING WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE RISK ASSESSMENT IDENTIFIED THE APPLICABLE RISKS AND DETERMINED THEY WERE ACCEPTABLE. DEVICE EVALUATION HAS YET TO BE COMPLETED BY THE THIRD PARTY LABORATORY. IF ANY DEVICE MALFUNCTIONS OR PROBLEMS ARE FOUND DURING THE EVALUATION, THIS SUBMISSION MAY BE UPDATED. AS OF THIS SUBMISSION THERE HAS BEEN NO INDICATION OF A DEVICE MALFUNCTION OR USE ERROR RESULTING IN THIS ADVERSE EVENT. THE INVESTIGATION COULD NOT DETERMINE A CAUSE FOR THIS EVENT. THIS SUBMISSION IS FOR 2 OF 2 PRODISC C DEVICES INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    PATIENT WAS DIAGNOSED/SCHEDULED FOR PRODISC C REMOVAL ON AN UNKNOWN DATE. REMOVAL WAS TO TAKE PLACE ON (B)(6) 2021 DUE TO NECK PAIN AND RADICULOPATHY. THERE WAS NO INDICATION OF DEVICE MALFUNCTION OR DEVICE PROBLEMS. IT IS UNKNOWN IF THE DEVICE WAS CAUSING/CONTRIBUTING TO THE NECK PAIN OR RADICULOPATHY. PRODISC C REMOVAL WAS SUCCESSFULLY COMPLETED ON (B)(6) 2021. THE 2-LEVEL PRODISC C CONSTRUCT WAS REMOVED FROM C5/6 AND C6/7. THERE WAS NO INDICATION WHAT THE DEVICES WERE REPLACED WITH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950196 PRODISC C US IMPLANT LARGE DEEP 5MM PROSTHESIS, INTERVERTEBRAL DISC MJO CENTINEL SPINE, LLC. 09.820.055S UNKNOWN 00843193112842

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention