BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C IMPLANT LARGE 5MM-STERILE

    MDR report key: 3921208 · Received July 9, 2014

    Report

    Report Number
    2530088-2014-10179
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 10, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP070001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IMPLANTED AT LEVEL C5-C6 ON (B)(6) 2014 WITH A PRO DISC-C. THE IMPLANT WAS REMOVED ON (B)(6) 2014 DUE TO THE PRO DISC- C MOVING OUT OF POSITION AND PATIENT PAIN, THE HARDWARE WAS FOUND TO BE INTACT; THE AREA WAS FUSED ONCE THE IMPLANT WAS REMOVED. THERE WAS NO REPORTED SURGICAL DELAY. REPORTEDLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400039 PRODISC-C IMPLANT LARGE 5MM-STERILE PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention