BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2931059 · Received January 28, 2013

    Report

    Report Number
    1030489-2013-00258
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    December 27, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN PATIENT MEDICAL RECORDS THAT THE PATIENT PRESENTED FOR SURGERY WITH "SEVERE, UNRELENTING NECK PAIN WITH PROMINENCE OF LEFT TRAPEZIAL PAIN, AT TIMES RIGHT BRACHIAL PAIN AND SOME PERSISTING PAIN CONSISTENT WITH C6 DISTRIBUTION TO THE LEFT HAND , THOUGH THE PATIENT HAD A PRIOR CARPAL TUNNEL SURGERY YEARS AGO AND NOTES SOME OF THOSE SYMPTOMS PERSISTING SINCE THAT TIME". "CT AND MRI SCANS, AS WELL AS PLAIN X-RAYS, SHOWED SPONDYLOLISTHESIS WITH 4MM MOTION ON FLEXION/EXTENSION AT C4-5 AND SIMILAR MOTION ON FLEXION/EXTENSION STUDIES AT C3-4. THERE IS BILATERAL NEURAL FORAMINAL STENOSIS AT C3-4, RIGHT-SIDED C5 FORAMINAL STENOSIS AND LEFT-SIDED C6 FORAMINAL STENOSIS PER IMAGING STUDIES WHICH CORRESPOND TO THESE UPPER EXTREMITY SYMPTOMS. THESE SYMPTOMS HAVE BEEN REFRACTORY TO EXTENSIVE CONSERVATIVE TREATMENT INCLUDING PAIN MANAGEMENT WITH EPIDURAL STEROID INJECTIONS, TRIGGER POINT INJECTIONS AND NARCOTIC ANALGESICS AS WELL AS PHYSICAL REHAB MEASURES." THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION FROM C3 TO C6 USING INSTRUMENTATION AND RHBMP-2/ACS. RHBMP-2/ACS WAS WRAPPED AROUND CERAMIC GRANULES MATRIX. PATIENT SHOWED GOOD ACTIVE MOTOR FUNCTION ON RECOVERY ROOM EXAM. AT 509 DAYS POST-OP, THE PATIENT PRESENTED FOR SURGERY STATUS POST ANTERIOR AS WELL AS POSTERIOR CERVICAL FUSION. CERVICAL AREA WAS FUSED DOWN TO T1 WITH BREAKDOWN AT LEVELS BELOW. THE PATIENT UNDERWENT POSTERIOR THORACIC FUSION AT T1-2. POSTERIOR THORACIC FUSION AT T2-3, 3-4, 4-5 WITH INSTRUMENTATION, AUTOGRAFT, RHBMP-2/ACS, CERAMIC GRANULES BLOCK GRAFTING, AND DEMINERALIZED BONE MATRIX GRAFTING. FACETS WERE DECORTICATED AND PACKED IN RHBMP-2/ACS THAT WAS SOAKED ONTO A 10ML CERAMIC BLOCK. THIS WAS PLACED IN EACH FACET JOINT ALONG WITH DEMINERALIZED BONE MATRIX AND LOCAL AUTO-BONE DUST. NO COMPLICATIONS WERE NOTED DURING SURGERY. THE PATIENT TOLERATED PROCEDURE WELL. REPORTEDLY, AT AN UNKNOWN TIME POST-OP, THE PATIENT ALLEGEDLY EXPERIENCED A FORMATION OF A KNOT NEAR T5, CONSTANT SWELLING AT T5, NUMBNESS AND WEAKNESS IN EXTREMITIES, NERVE DAMAGE, AND SWELLING IN THE NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36438 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110908AAH

    Patients

    Seq Age Sex Outcome Treatment
    1