BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2802826 · Received October 24, 2012

    Report

    Report Number
    1030489-2012-01961
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. ALSO SEE MEDWATCH REPORT NUMBERS 1030489-2012-01865 AND 1030489-2012-01960.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE FOR REMOVAL OF THE INTERBODY CAGE AT L3-4 DUE TO "REPEATED RETROPULSION. HE HAD DEVELOPED RADICULAR SYMPTOMS AGAIN AND IMAGING CONFIRMED THE CAGE HAD AGAIN SUBSIDED." THE CAGE WAS REMOVED. "A FULL INSPECTION OF THE NERVOUS STRUCTURES WAS PERFORMED. NO DAMAGE OR CSF EGRESS WAS NOTED." "SOLID ARTHRODESIS WAS NOTED ANTERIORLY AND LATERALLY." THE SPACE OCCUPIED BY THE CAGE WAS FILLED WITH RHBMP-2/ACS SPONGES FOR ARTHRODESIS. GEL FOAM AND SURGICELL WERE PLACED AS A BARRIER VENTRAL TO THE SAC AND DORSAL TO THE SPONGES. ALLEGEDLY, POST-OPERATIVELY, THE PATIENT HAS DEVELOPED "EXCRUCIATING PAIN, SEVERE MUSCLE SPASMS, CAGE MIGRATION (TWICE), DURA SAC PUNCTURE, BONE GROWTH, NUMBNESS, BLADDER PROBLEMS, SPINAL FLUID LEAKS, CEREBRAL FLUID LEAKS, HEADACHES, LEFT SIDE PARALYSIS, SLAPFOOT, SLIGHT MOVEMENT AT BIG TOE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GEL FOAM AND SURGICELL