BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC C US IMPLANT

    MDR report key: 12010714 · Received June 16, 2021

    Report

    Report Number
    3007494564-2021-00053
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    May 20, 2021
    Report Date
    June 16, 2021
    Manufacturer
    CENTINEL SPINE, LLC.
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIMITED INFORMATION PROVIDED FROM THIS CASE DOES NOT INDICATE WHY THE PRODISC C DEVICE WAS REMOVED, ANY PATIENT COMPLICATIONS, OR ANY INDICATION THAT AN INJURY HAD OCCURRED. THIS UNKNOWN REASON FOR REMOVAL LED TO A DETERMINATION BASED ON PREVIOUS EVENTS THAT THE REMOVAL MAY BE TO PRECLUDE SERIOUS INJURY THUS AN MDR SUBMISSION IS REQUIRED. DHR REVIEW COULD NOT BE COMPLETED AS PART AND LOT NUMBERS WERE NOT PROVIDED. COMPLAINT HISTORY INDICATES THAT THE RATE OF COMPLAINTS EQUATES TO A 'REMOTE' PROBABILITY OF HARM. THE RISK ASSESSMENT DETERMINED THE ASSOCIATED RISKS ARE IDENTIFIED, MITIGATED, AND ACCEPTED. NO DEVICE WAS RETRIEVED BY THE FACILITY FOR EVALUATION. RETRIEVAL OF THE DEVICE WAS REQUESTED, BUT THE HOSPITAL DISPOSED OF THE DEVICE BEFORE IT COULD BE RECOVERED FOR EVALUATION. THE INVESTIGATION COULD NOT DETERMINE A CAUSE FOR THIS EVENT. THIS SUBMISSION IS FOR 1 OF 1 DEVICES INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A PRODISC C REMOVAL SURGERY ON (B)(6) 2021. LIMITED INFORMATION HAS BEEN PROVIDED REGARDING THIS REMOVAL CASE. THERE HAS BEEN NO INDICATION AS TO THE REASON THE PRODISC C DEVICE WAS EXPLANTED. THERE HAS BEEN NO INDICATION OF ANY PATIENT COMPLICATIONS OR SYMPTOMS. THERE HAS BEEN NO INDICATION OF A DEVICE MALFUNCTION OR PROBLEM CONTRIBUTING TO THE NEED FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907163 PRODISC C US IMPLANT PROTHESIS, INTERVERTEBRAL DISC MJO CENTINEL SPINE, LLC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention