BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 5319829 · Received December 22, 2015

    Report

    Report Number
    1030489-2015-03563
    Event Type
    Injury
    Date Received
    December 22, 2015
    Report Date
    November 23, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(6) 1999 PATIENT UNDERWENT A MRI OF CERVICAL SPINE. REPORTED AS SHOWING MILD HYPERTROPHIC CHANGES AT C3-4 AND C4-5 WITH DISC BULGING AT C5-6 AND C6-7 CREATING MODERATE SPINAL STENOSIS WITH NARROWING OF THE NEURAL FORAMINA. NO NUCLEAR HERNIATION WAS DETECTED. ON (B)(6) 2003 THE PATIENT UNDERWENT THE FOLLOWING SURGERIES: REMOVAL OF C5 TO C7 ANTERIOR CERVICAL PLATE INCLUDING SCREWS, CORRECTION OF PSEUDOARTHROSIS OF C5-6 WITH PREPARATION OF SMITH-ROBINSON FUSION BED AND CLEAN OUT OF THE DISC SPACE, CORRECTION OF PSEUDOARTHROSIS OF C6-7 WITH MINIMAL DISCECTOMY AND PREPARATION OF SMITH-ROBINSON FUSION BED, ALLOGRAFT FUSION OF C5-6 AND C6-7 USING ILIAC CREST ALLOGRAFT TAILORED TO MEASURE FOR A SMITH-ROBINSON FUSION TO TREAT THE FOLLOWING DIAGNOSIS: PSEUDOARTHROSIS OF C5-6 AND C6-7 WITH DEGENERATIVE CERVICAL DISC DISEASE AND INSTABILITY. ON (B)(6) 2004 THE PATIENT PRESENTED FOR A FOLLOW-UP VISIT DUE TO SEVERE NECK PAIN. NEUROLOGIC: THE NEUROLOGIC FUNCTION IN THE UPPER EXTREMITIES WAS NOTABLE FOR NUMBNESS DIFFUSELY IN THE RIGHT HAND. MYELOGRAM CT SCAN DEMONSTRATES NO CLEAR EVIDENCE OF PERSISTENT NEUROLOGIC IMPINGEMENT BUT CLEARLY SHOWS MOTION AT THE UNUNITED LEVEL C5-6 AND C6-7. IMPRESSION: C5-6, C6-7 ANTERIOR NONUNION OF CERVICAL SPINE. ON (B)(6) 2004 THE PATIENT PRESENTED WITH CHIEF COMPLIANT OF NECK PAIN. ON (B)(6) 2004 THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: C5-6 AND C6-7 POSTERIOR SPINAL FUSION WITH SUMMIT SEGMENTAL LATERAL MASS INSTRUMENTATION AND BONE MORPHOGENETIC PROTEIN WITH ALLOGRAFT BONE AND APPLICATION AND REMOVAL OF GARDENER-WELLS TONGS TO TREAT C5-C6 AND C6-C7 PSEUDOARTHROSIS. OP-NOTES: X-RAY CONFIRMED THAT THE APPROPRIATE LEVEL WAS MAINTAINED ALTHOUGH IT DID NOT DETAIL THE SCREWS THEMSELVES. NOW A ROD WAS PLACED. NUTS WERE PLACED. COMPRESSION WAS APPLIED. THE NUTS WERE TIGHTENED AND TORQUED. PRIOR TO PLACEMENT OF THE SCREWS THE ENTIRE LAMINA WAS DECORTICATED WITH MIDAS REX 6MM ROUGH BUR ALONG WITH THE FACET JOINTS. MORSELIZED CANCELLOUS BONE WAS ADDED BETWEEN A SANDWICH OF COLLAGEN CARRIERS IMPREGNATED WITH BONE MORPHOGENIC PROTEIN BILATERALLY. TWO ADDITIONAL COLLAGEN SPONGES WERE PLACED ON EACH IN LAYERS WITH RUNNING INTERRUPTED #1 VICRYL FOR THE FASCIA, 2-0 VICRYL SUBCUTANEOUS AND 1/8TH INCH HEMOVAC DRAIN, AND THEN STAPLES AND NYLON SUTURES ON THE SKIN. HE APPEARED TO TOLERATE THE PROCEDURE WELL AND WAS ABOUT TO UNDERGO EXTUBATION AND RETURN TO RECOVERY. ON (B)(6) 2004 THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: REMOVAL OF RIGHT LATERAL MASS SCREW AND REVISION OF INSTRUMENTATION TO TREAT C6 RADICULOPATHY. ON (B)(6) 2004 THE PATIENT PRESENTED DUE TO RIGHT ARM PAIN. X-RAYS: CT SCAN AS DESCRIBED ABOVE. IMPRESSION: C6 NUMBNESS, RIGHT UPPER EXTREMITY SECONDARY TO NEUROLOGICAL IMPINGEMENT FROM LATERAL MASS SCREW. ON (B)(6) 2005 PATIENT PRESENTED DUE TO NECK PAIN, RIGHT ARM PAIN AND NUMBNESS. IMPRESSION: C5-6, C6-7 SPONDYLOSIS WITH RADICULOPATHY AND FORAMINAL STENOSIS. ON (B)(6) 2005 THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: REMOVAL OF RIGHT SEGMENTAL POSTERIOR MASS INSTRUMENTATION FROM CERVICAL SPINE, C5 TO C7, APPLICATION AND REMOVAL OF MAYFIELD TONGS TO TREAT C6 RADICULOPATHY. ON (B)(6) 2005 THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: LAMINECTOMY WITH MEDIAL FACETECTOMY AND EXTENSIVE FORAMINOTOMY ON THE LEFT TO DECOMPRESS EXITING C6 NERVE ROOT, LAMINECTOMY C6-7 WITH MEDIAL FACETECTOMY AND C6-7 FORAMINOTOMY TO DECOMPRESS EXITING LEFT C7 NERVE ROOT TO TREAT THE PRE-OP DIAGNOSIS: FORAMINAL STENOSIS AT C5-6 PRODUCING COMPRESSION OF C6 NERVE ROOT, FORAMINAL STENOSIS C7 PRODUCING COMPRESSION OF EXITING C7 NERVE ROOT (LEFT). ON (B)(6) 2006 THE PATIENT PRESENTED DUE TO POSTERIOR NECK PAIN, TINGLING AND NUMBNESS IN HIS RIGHT UPPER EXTREMITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843894 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M112001AAA.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other