BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY SPINE

    MDR report key: 634761 · Received September 7, 2005

    Report

    Report Number
    634761
    Event Type
    Injury
    Date Received
    September 7, 2005
    Date of Event
    August 11, 2005
    Report Date
    September 7, 2005
    Manufacturer
    DEPUY SPINE
    Product Code
    MJO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UNDERWENT DEPUY TOTAL DISK ARTHROPLASTY IN 05. THREE WEEKS LATER PRESENTED TO ER WITH SEVERE BACK PAIN. X-RAY SHOWED IMPLANT HAD MIGRATED ANTERIORLY WHERE IT WAS COMPLETELY DISLODGED FROM L5-S1 DISC SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY SPINE ENDOPLATE & SLIDING CORE MJO DEPUY SPINE ENDPLATES WL046C013
    2 DEPUY SPINE ENDPLATE & SLIDING CORE MJO DEPUY SPINE ENDPLATES WL04E042
    3 DEPUY SPINE ENDPLATE & SLIDING CORE MJO DEPUY SPINE ENDPLATES WL047C023

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention