BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODISC C VIVO US IMPLANT

    MDR report key: 20956335 · Received December 17, 2024

    Report

    Report Number
    3007494564-2024-00101
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Report Date
    December 16, 2023
    Manufacturer
    CENTINEL SPINE, LLC
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN MDR IS INDICATED FOR THIS COMPLAINT. IT WAS REPORTED THAT AN IMAGE FROM THE FACEBOOK GROUP "SPINAL IMPLANTS IDENTIFICATION GROUP" SHOWED A MIGRATED VIVO IMPLANT. NO INFORMATION IS KNOWN ABOUT THE CASE. A DHR REVIEW COULD NOT BE COMPLETED AS PART NUMBER AND LOT NUMBER WERE NOT PROVIDED AND COULD NOT BE DETERMINED DURING THE INVESTIGATION. COMPLAINT TRENDING FOUND THAT THE RATE OF COMPLAINTS IS WITHIN THE LEVEL OUTLINED IN THE RISK DOCUMENTATION. A REVIEW OF THE RISK DOCUMENTATION FOUND THAT HAZARDS ASSOCIATED WITH THE COMPLAINT ARE IDENTIFIED AND MITIGATED TO A LEVEL WHERE THE CLINICAL BENEFITS OUTWEIGH THE RISKS. THE IMPLANT WAS NOT RETURNED FOR DEVICE EVALUATION, IT IS UNKNOWN IF THE IMPLANT HAS BEEN REMOVED. IMAGING CONFIRMS THAT THE IMPLANT HAS MIGRATED. IT IS CONFIRMED THAT THE IMPLANT HAS MIGRATED, A REASON FOR THE MIGRATION IS UNKNOWN. THE SUBMISSION IS 1 OF 1 DEVICES INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    REP SENT IMAGE FROM FACEBOOK GROUP "SPINAL IMPLANTS IDENTIFICATION GROUP" THAT SHOWED A MIGRATED VIVO IMPLANT. NO INFORMATION IS KNOWN ABOUT THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438481 PRODISC C VIVO US IMPLANT PROSTHESIS, INTERVERTEBRAL DISC MJO CENTINEL SPINE, LLC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown