BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2665691 · Received July 23, 2012

    Report

    Report Number
    1030489-2012-01195
    Event Type
    Injury
    Date Received
    July 23, 2012
    Report Date
    June 20, 2018
    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    REPORTEDLY THE PATIENT HAS DEVELOPED "SERIOUS PAIN, AND A MENTAL ANGUISH ABOUT THINGS GETTING WORSE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: CERVICAL RADICULOMYELOPATHY; ADVANCED COMPLEX DEGENERATIVE DISC DISEASE OF THE CERVICAL SPINE; MIGRAINE HEADACHES; HYPERTENSION; ROTATOR CUFF INJURY. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR CERVICAL DISCECTOMY AND DECOMPRESSION IN PREPARATION OF ENDPLATES AT THE C3/4 INTERSPACE; INCORPORATION OF THE ALLOGRAFT MEASURING 11 X 11 X 5 NUN, PREFILLED WITH BONE MORPHOGENETIC PROTEIN (BMP) MATERIAL; INTRAOPERATIVE MONITORING WITH SOMATOSENSORY-EVOKED RESPONSES, MOTOR-EVOKED RESPONSES, AND ELECTROMYELOGRAM (EMG); INTRAOPERATIVE FLUOROSCOPY. NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED.

    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 Other