BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2760817 · Received September 26, 2012

    Report

    Report Number
    1030489-2012-01697
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    January 29, 2013
    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY TO TREAT RADICULITIS, LUMBAR STENOSIS AND PAINFUL INSTRUMENTATION. THE SURGERY CONSISTED OF HARDWARE REMOVAL, DISCECTOMY, DECOMPRESSION AND POSTEROLATERAL ARTHRODESIS AT L5-S1. PER THE OPERATIVE NOTES, 'ALL NERVE ROOTS WERE WELL DECOMPRESSED. THE DURA WAS MOBILIZED. THERE WAS A SIGNIFICANT AMOUNT OF OSTEOPHYTE FORMATION, AS WELL AS ADHESIONS' DISCECTOMY WAS PERFORMED, AS WELL AS THE INTERBODY PROSTHESIS WAS REMOVED. AT COMPLETION, ALL NERVE ROOTS WERE WELL DECOMPRESSED. THE POSTERIOR AND LATERAL GUTTERS WERE DECORTICATED DOWN TO PUNCTATE BLEEDING BONE, BACKED WITH AUTOGENOUS BONE [RHBMP-2/ACS] AND CONNECTORS WERE THEN PLACED ONTO THE PEDICLE SCREWS.' NO COMPLICATIONS WERE NOTED. AT 243 DAYS POST-OP, NOTES FROM THE PATIENT'S OUTPATIENT THERAPY CHART STATE THE 'PATIENT ONLY TOLERATING PASSIVE TREATMENT WITH MODALITIES TO REDUCE PAIN AND INFLAMMATION AT THIS TIME DUE TO SEVERE PAIN. HE DOES NOT HANDLE ROM EXERCISE AT THIS TIME. PATIENT C/O SEVERE PAIN THROUGHOUT HIS BODY.' IT WAS NOTED THAT THE PATIENT WOULD BENEFIT FROM A HOME TENS UNIT TO CONTROL HIS CHRONIC PAIN. PATIENT WAS TREATED WITH US, ICE MASSAGE, CP, IC, AND IONTOPHORESIS WITH DEXAMETHASONE.

    Description of Event or Problem · 1

    REPORTEDLY THE PATIENT DEVELOPED "SIGNIFICANT PAIN, AND IT HAS SERIOUSLY LIMITED MY PHYSICAL MOVEMENT."

    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 M110607AAE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention