BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC C US IMPLANT LARGE-DEEP 5MM

    MDR report key: 11938766 · Received June 4, 2021

    Report

    Report Number
    3007494564-2021-00048
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    May 10, 2021
    Report Date
    June 2, 2021
    Manufacturer
    CENTINEL SPINE, LLC.
    Product Code
    MJO
    UDI-DI
    00843193112842
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PATIENT RECEIVED A PRODISC C US IMPLANT AT THE C4/5 LEVEL ON (B)(6) 2020. ON AN UNKNOWN DATE, THE PATIENT WAS DIAGNOSED WITH HETEROTOPIC OSSIFICATION AT THE PRODISC C LEVEL. THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2021 TO REMOVE THE PRODISC C IMPLANT AND REPLACE IT WITH A SYNTHES ZERO P CAGE AND SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838522 PRODISC C US IMPLANT LARGE-DEEP 5MM PROSTHESIS, INTERVERTEBRAL DISC MJO CENTINEL SPINE, LLC. 09.820.055S H686884 00843193112842

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention