BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4484794 · Received February 4, 2015

    Report

    Report Number
    1030489-2015-00230
    Event Type
    Death
    Date Received
    February 4, 2015
    Report Date
    March 14, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2007, PATIENT UNDERWENT FOLLOWING PROCEDURE: POSTERIOR CERVICAL FUSION, C2-3, POSTERIOR CERVICAL INSTRUMENTATION, C2-3; HARVEST OF LOCAL ILIAC CREST BONE GRAFT; USE OF RHBMP-2/ACS; INTRAOPERATIVE SPINAL CORD MONITORING; FOR PRE-OP DIAGNOSIS OF: UNSTABLE C2-3 INJURY. INDICATIONS: PATIENT FELL OF SURFBOARD AND INJURED HIS CERVICAL SPINE. MRI OF LUMBAR SPINE DID NOT SHOWED ANY INSTABILITY. RADIOGRAPH OBTAINED IN COLLAR SHOWED SUBLUXATION OF 4.5MM. PER-OP NOTES: ".. THERE WAS EXCESSIVE AMOUNT OF MOTION BETWEEN C2 AND C3. THIS WAS MORE PRONOUNCED TOWARDS RIGHT SIDE. THE FACETS BILATERALLY WERE INJURED AND WERE COMPLETELY DISRUPTED OVER RIGHT AND PARTIALLY DISRUPTED OVER LEFT. A HIGH SPEED BURR WAS USED TO DECORTICATE THE POSTERIOR ELEMENT AT C2 AND C3. RHBMP-2/ACS HAD BEEN PREPPED AND THIS WAS LAID OVER THE C2-3 LEVEL AND THE CANCELLOUS AUTOGRAFT WAS PLACED ON TOP OF THIS.. NO COMPLICATIONS WERE REPORTED.."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS ADMITTED TO HOSPITAL IN (B)(6) 2007 FOR UNSPECIFIED REASON. EIGHT DAYS LATER, THE PATIENT UNDERWENT POSTERIOR CERVICAL SPINAL FUSION ON THE CERVICAL REGION OF HIS SPINE FROM VERTEBRAE C2-C3 USING RHBMP-2/ACS. PATIENT'S POST-OPERATIVE PERIOD WAS MARKED BY PROGRESSIVE SPINAL, BACK AND RIB CAGE CHRONIC PAIN AND EVENTUAL DIAGNOSIS OF MULTIPLE MYELOMA. IN ORDER TO ATTEMPT TO TREAT PATIENT¿S CANCER, A PROLONGED, EXTENSIVE AND PAINFUL COURSE OF MEDICAL TREATMENTS WAS NECESSITATED, INCLUDING, BUT NOT LIMITED TO CHEMOTHERAPY TREATMENTS. THE PATIENT DIED FROM MULTIPLE MYELOMA AND RELATED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80787 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 Death| R