BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAK INTERBODY FUSION

    MDR report key: 307173 · Received December 3, 2000

    Report

    Report Number
    MW1020516
    Event Type
    Injury
    Date Received
    December 3, 2000
    Date of Event
    March 18, 1999
    Report Date
    December 3, 2000
    Manufacturer
    SPINE-TECH
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD AN ACCIDENT AND WAS DIAGNOSED WITH DEGENERATIVE DISC L5-S1. WAS SOLD ON PROCEDURE. NEVER TOLD ABOUT ADVERSE PROBLEMS, PERFORMED BAK INTERBODY FUSION. NOW THE CAGES ARE MOVING. IF YOU LOOK AT DIFFERENT HEALTH FORUMS AND SEARCH FAILED FUSIONS YOU WILL FIND MANY PEOPLE COMPLAINING OF PAIN AFTER BAK SURGERY AND THAT THE SURGERY HAS RUINED THEIR LIVES AND RPTR'S. NOW RPTR HAS TO HAVE FURTHER INSTRUMENTATION TO CORRECT A SURGERY THAT WAS HALF DONE. THERE SHOULD HAVE BEEN RODS AND SCREWS WITH THE BAK CAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAK INTERBODY FUSION * MAX SPINE-TECH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| S