BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1993632 · Received February 16, 2011

    Report

    Report Number
    1030489-2011-00132
    Event Type
    Injury
    Date Received
    February 16, 2011
    Report Date
    January 18, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANDERSON, DAVID W. ET AL. "POSTOPERATIVE CERVICAL MYELOPATHY AND CORD COMPRESSION ASSOCIATED WITH THE USE OF RH-BMP-2 IN POSTERIOR CERVICAL DECOMPRESSION, INSTRUMENTATION, AND ARTHRODESIS: A REPORT OF TWO CASES". SPINE 2011. POSTERIOR INSTRUMENTATION INCLUDING LATERAL MASS SCREWS (DETAILS NOT PROVIDED) AUTOGRAFT (DETAILS NOT PROVIDED). (B)(4). MULTIPLE PRODUCTS 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. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE CLINIC WITH NECK PAIN AND LEFT UPPER EXTREMITY NUMBNESS AND TINGLING TWO YEARS AFTER A WORK INJURY. AFTER 4 MONTHS OF CONSERVATIVE TREATMENT THE PATIENT UNDERWENT A 2-LEVEL ANTERIOR CERVICAL DECOMPRESSION AND FUSION (ACDF). HIS SYMPTOMS IMPROVED FOR A SHORT TIME BUT GRADUALLY BEGAN TO RETURN. THE PATIENT UNDERWENT C5/C7 POSTERIOR INSTRUMENTATION, ARTHRODESIS, AND C6 COMPLETE LAMINECTOMY USING RHBMP-2 (4.2 MG). THE PATIENT BEGAN PHYSICAL AND OCCUPATIONAL THERAPY. THE HOSPITAL STAY WAS UNEVENTFUL. THE PATIENT'S PAIN WAS WELL CONTROLLED AT THE TIME OF DISCHARGE HOME ON POST-OP DAY FOUR. ON THE DAY AFTER DISCHARGE, THE PATIENT EXPERIENCED AN ACUTE ONSET OF BILATERAL UPPER AND LOWER EXTREMITY WEAKNESS TO THE POINT OF BEING UNABLE TO RAISE HIMSELF FROM A SEATED OR LYING POSITION. HE ADDITIONALLY COMPLAINED OF A NEW ONSET OF DECLINE IN PROPRIOCEPTION FOR HIS RIGHT UPPER EXTREMITY. THE PATIENT WAS IMMEDIATELY ADMITTED TO THE HOSPITAL AND UNDERWENT A CT MYELOGRAM THAT SHOWED A COMPLETE BLOCKAGE OF CONTRAST FLOW AT C6/C7 CONSISTENT WITH A SEVERE SPINAL STENOSIS AT THIS LEVEL. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR EVACUATION OF THE FLUID COLLECTION. UPON OPENING THE PREVIOUS INCISION, APPROXIMATELY A 10-ML VOLUME OF SERROUS FLUID WAS IDENTIFIED SURROUNDING THE SPINAL CORD AND REMOVED. THE WOUND WAS INSPECTED, AND FIBRINOUS MATERIAL ON THE SPINAL CORD WAS GENTLY REMOVED. NO CONTRACTION OF THE DURA WAS NOTED. THE WOUND WAS CLOSED WITH A DRAIN. THE PATIENT NOTICED IMMEDIATE IMPROVEMENT IN HIS NEUROLOGICAL FUNCTION IN THE RECOVERY ROOM. THE DRAIN WAS REMOVED AFTER A FEW DAYS. PRIOR TO DISCHARGE, THE PATIENT EXPERIENCED SIGNIFICANT IMPROVEMENT IN BOTH MOTOR AND SENSORY FUNCTION IN HIS ARMS AND HANDS. THE PATIENT'S GAIT IMPROVED; HE WAS ABLE TO AMBULATE WITH A WALKER. THE REMAINDER OF THE HOSPITAL STAY WAS UNEVENTFUL. THE PATIENT WAS TRANSITIONED TO THE REHABILITATION FLOOR FOR FURTHER CONDITIONING PRIOR TO DISCHARGE. THE PATIENT WAS DISCHARGED TO HOME WITH OUTPATIENT PHYSICAL THERAPY. AT HIS 4-MONTH FOLLOW-UP VISIT, THE PATIENT HAD FULL STRENGTH IN HIS BILATERAL UPPER AND LOWER EXTREMITIES. HIS AMBULATION CONTINUED TO IMPROVE. THE PATIENT ONLY REQUIRED A CANE FOR LONG-DISTANCE WALKING.

    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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Hospitalization| R