BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 4851611 · Received June 17, 2015

    Report

    Report Number
    2530088-2015-10478
    Event Type
    Injury
    Date Received
    June 17, 2015
    Report Date
    June 4, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP070001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UNKNOWN WHEN PAIN STARTED OR WHEN IMPLANT MIGRATED. THIS REPORT IS FOR UNKNOWN 7MM MEDIUM PRODISC-C IMPLANT/UNKNOWN LOT NUMBER. ORIGINAL IMPLANT DATE UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND 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.

    Additional Manufacturer Narrative · 1

    (B)(4): 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 THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2015 TO REMOVE A 7MM MEDIUM PRODISC-C IMPLANT AT C4-5 DUE TO MIGRATION OF THE IMPLANT ANTERIORLY, PAIN, AND DIFFICULTY SWALLOWING. THE PATIENT HAD UNDERGONE A TOTAL DISC REPLACEMENT ON AN UNKNOWN DATE. IT WAS DETERMINED BY ANOTHER SURGEON THAT THE ENTIRE IMPLANT HAD MIGRATED ANTERIORLY. THE PATIENT HAD PAIN AND DIFFICULTY SWALLOWING. THE PATIENT WAS REVISED TO A TWO-LEVEL FUSION WITH A COMPETITOR'S PRODUCT. THERE WAS NO REPORTED SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395204 PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention