BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C IMPLANT MEDIUM

    MDR report key: 2042157 · Received March 28, 2011

    Report

    Report Number
    2530088-2011-00088
    Event Type
    Injury
    Date Received
    March 28, 2011
    Report Date
    March 11, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PATIENT STATUS POST FUSION LEVEL C5-C7 DATE UNKNOWN WAS IMPLANTED WITH A PRODISC-C AT LEVEL C4-C5 THE DATE IS UNKNOWN. PATIENT RETURNED TO SURGEON COMPLAINING OF PAIN, SURGEON NOTED TOO MUCH HYPERMOBILITY. SURGEON REMOVED THE HARDWARE ON (B)(6) 2011 AND REVISED THE PATIENT TO ZERO-P.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODISC-C IMPLANT MEDIUM PRODISC-C IMPLANT MJO SYNTHES BRANDYWINE NA 5804026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention NI.