BEUDAMED
    FDA Adverse Event Summary report: N

    RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN 2 ABSORBABLE C0

    MDR report key: 328516 · Received April 19, 2001

    Report

    Report Number
    MW4002983
    Date Received
    April 19, 2001
    Date of Event
    May 1, 1998
    Report Date
    April 5, 2001
    Manufacturer
    MEDTRONIC SOFAMORE DANEK USA, INC.
    Product Code
    MPW
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER PARTICIPATING IN A STUDY INVOLVING RECOMBINANT HUMAN BONE MORPHOGENTIC PROTEIN 2 ABSORBABLE COLLAGEN SPONGE WITH AUTOGRAPH BONE DOWLS FOR ANTERIOR LUMBAR INTERBODY FUSION IN PTS WITH DEGENERATIVE DISK DISEASES L5 S1, IDE G970124, DR CLINICAL INVESTIGATOR THE INDIVIDUAL EXPERIENCED SEVERE PAIN IN NECK AND LEGS AND CAME DOWN WITH ASTHMA AND FIBROMYALGIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17979 RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN 2 ABSORBABLE C0 RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN 2 ABSORBABLE CO MPW MEDTRONIC SOFAMORE DANEK USA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR