BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2931058 · Received January 28, 2013

    Report

    Report Number
    1030489-2013-00257
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    December 7, 2015
    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)(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. 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

    (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PROGRESSIVE LEG PAIN. PATIENT HAD BILATERAL NUMBNESS GOING DOWN LEG FOLLOWING PRIOR DECOMPRESSION (DATE UNKNOWN). PATIENT STILL HAD PERSISTENT NUMBNESS AND BACK PAIN INCREASED ALONG WITH PROGRESSIVE LEG PAIN OVER THE PAST YEAR TO THE POINT THAT THE PATIENT WAS HAVING TROUBLE WALKING. STUDIES SHOWED THAT PATIENT HAD MOBILE SPONDYLOLISTHESIS AT L4-5 AND MRI INTERPRETATION SHOWED THAT PATIENT PROFOUND CONGENITAL SPINAL STENOSIS STILL PRESENT EVEN AFTER THE DECOMPRESSION AT L3-4 AND L4-5 AND SOMEWHAT AT L2-3. THE PATIENT UNDERWENT MYELOGRAM. SHORTLY AFTER MYELOGRAM PATIENT STARTED DEVELOPING PROGRESSIVELY MORE AND MORE LEG WEAKNESS BILATERALLY. MYELOGRAM SHOWED THAT PATIENT HAD PROFOUND AND ADVANCED PRIMARY THORACIC STENOSIS IN THE T10, T11 AND T12 AREA WHERE THE SPINAL CANAL WAS BASICALLY 4 OR 5 MILLIMETERS IN DIAMETER. PATIENT WAS TAKEN TO SURGERY IMMEDIATELY FOR DECOMPRESSION AND FUSION. PATIENT UNDERWENT THORACIC LAMINECTOMY OF T10-T12 AND LUMBAR LAMINECTOMY, FORAMINOTOMY AND FACETECTOMY AT L2/3 AND L3/4 BILATERALLY, AND L4/5 AND L5/S1 BILATERALLY (REOPERATION OF LOWER TWO LEVELS). PATIENT UNDERWENT L1 TO L5 POSTEROLATERAL SPINAL FUSION WITH PEDICLE SCREW INSTRUMENTATION WITH CROSSLINKS AND T10-T12 POSTERIOR SPINAL FUSION WITH PEDICLE SCREW INSTRUMENTATION WITH CROSSLINKS USING LOCAL BONE GRAFT COMBINED WITH CERAMIC GRANULES COMBINED RHBMP-2/ACS . PER THE OPERATIVE NOTES, 'DUE TO PATIENT'S BODY HABITUS, PRIOR SURGERY, EXTENSIVE SCARRING, THERE WAS A SIGNIFICANT LOSS OF NORMAL ANATOMICAL STRUCTURES; MUCH MORE TIME INVOLVED IN DISSECTING OUT AND IDENTIFYING THE CRITICAL STRUCTURES BOTH DECOMPRESSION AND INSTRUMENTATION WISE, AND OF COURSE, THE EMERGENT NATURE OF THE PROCEDURE AND, OF COURSE, THE CONGENITAL ABNORMALITIES OF SEVERE STENOSIS ALL MADE [SURGERY] A MUCH HIGHER DEGREE DIFFICULT CASE.' NO ADDITIONAL COMPLICATIONS WERE NOTED DURING SURGERY. PATIENT WAS ADMITTED TO HOSPITAL FOR RECOVERY. OVER THE COURSE OF THE NEXT SEVERAL DAYS, PATIENT 'REGAINED FULL STRENGTH IN BILATERAL LOWER EXTREMITIES AND HAD SIGNIFICANT IMPROVEMENT IN HIS NUMBNESS AND TINGLING IN BILATERAL LOWER EXTREMITIES AND REPORTED THAT THE SENSATION IN HIS LOWER EXTREMITIES WAS ALMOST BACK TO NORMAL. HE ALSO HAD IMPROVEMENT IN CIRCULATION TO HIS LOWER EXTREMITIES.' PATIENT WAS EVALUATED FOR PHYSICAL THERAPY AND NEUROLOGICAL CONSULT. AT THE TIME OF DISCHARGE, PATIENT WAS AMBULATING IN LUMBAR BRACE WITH PHYSICAL THERAPY AND HAD 5 OUT OF 5 STRENGTH IN BILATERAL LOWER EXTREMITIES. REPORTEDLY, AT AN UNKNOWN TIME POST-OP, THE PATIENT ALLEGEDLY BEGAN EXPERIENCING INCREASED PARALYSIS, LOSS OF SEXUAL FUNCTION, LOSS OF FEELINGS IN LEGS AND LOWER BODY, AND MUSCLE SPASMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008, PATIENT UNDERWENT FOLLOWING PROCEDURE: 1. 1. L1 TO L5 POSTEROLATERAL FUSION, 2. L2 TO L5 POSTERIOR INSTRUMENTATION 6.35 TITANIUM WITH X10 CROSSLINKS TIMES 1, 3. T10 TO T12 POSTERIOR SPINAL FUSION, 4. T10 TO T12 POSTERIOR INSTRUMENTATION, 6.35 TITANIUM WITH X10 CROSSLINK, 5. LOCAL BONE GRAFT COMBINED WITH BONE GRAFT COMBINED WITH 4 LARGE RHBMP-2 KITS; FOR PRE-OP DIAGNOSIS OF: 1. PROGRESSIVE CAUDA EQUINA SYNDROME WITH SPINAL CORD COMPRESSION DUE TO SEVERE PRIMARY THORACIC STENOSIS AT T10, 11, 12, 2. SEVERE SPINAL STENOSIS FROM L2 TO L4, 3. UNSTABLE SPINE L4-5 WITH MOBILE SPONDYLOLISTHESIS. PER-OP NOTES: 6.5 X 40 SCREWS WERE PLACED AT L2 AND 45 SCREWS AT L3, 4, AND 5. THIS PROCEDURE WAS PERFORMED BILATERALLY. AP AND LATERAL X-RAYS SHOWED GOOD POSITION OF THE SCREWS. TWO RODS AND CROSSLINK WAS PLACED WHICH REDUCED SPONDYLOLISTHESIS BY AT LEAST 50%. 5.5 X 35 SCREWS WERE PLACED AT T 10, 11, 12. RODS AND CROSSLINK WERE PLACED AND X-RAYS CONFIRMED THEIR POSITION. AUTOGRAFT WAS PLACED FROM L2 TO L5 BETWEEN THE TRANSVERSE PROCESSES, FOLLOWED BY PLACEMENT OF RHBMP-2 AND BONE GRAFT. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37115 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 00058 YR Other