BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3142432 · Received June 3, 2013

    Report

    Report Number
    1030489-2013-02050
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    October 8, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012 THE PATIENT PRESENTED CHRONIC BACK AND NECK PAIN ATTRIBUTED TO L3-4 AND L4-5 SEVERE LUMBAR DEGENERATIVE DISEASE WITH STENOSIS. THE PATENT UNDERWENT A SURGERY THAT ENTAILED A BILATERAL INFERIOR LAMINOTOMY OF THE L3, BILATERAL SUPERIOR LAMINOTOMY OF L4, MEDIAL FACETECTOMY, FORAMINOTOMY FOR DECOMPRESSION OF BILATERAL L3 AND L4 NERVE ROOTS, BILATERAL INFERIOR LAMINOTOMY OF L4, SUPERIOR LAMINOTOMY OF L5, MEDIAL FACETECTOMY, FORAMINOTOMY FOR DECOMPRESSION, BILATERAL SUPERIOR LAMINOTOMY OF L4 AND L5 NERVES ROOTS; PLACEMENT OF SEGMENTAL TRANSPEDICULAR HARDWARE BILATERALLY, L3, L4, L5; AND, A POSTERIOR LATERAL ARTHRODESIS USING MASTER CRAFT GRAFT COMPRESSION RESISTANT MATRIC AUGMENTED WITH RHBMP-2/ACS AND CANCELLOUS CHIPS AND LOCAL MORSELIZED BONE GRAFT. PER THE OPERATIVE NOTES: "... AT THIS TIME, ATTENTION TURNED THE PLACEMENT OF TRANSPEDICULAR HARDWARE. THE STARTING POINT WAS IDENTIFIED ANATOMICALLY AND THE PEDICLES WERE SOUNDED WITH A NIM STEFFEE PROBE WITH NO ABNORMAL DISCHARGE. THE PEDICLES WERE TAPPED AND MEDTRONIC POLYAXIAL SCREWS WERE PLACED WITH EXCELLENT BONE PURCHASE FOR ALL 6 SCREWS. THIS WAS THE TRANSPEDICULAR APPROACH.... THE TRANSVERSE DECORTICATED AS WE WENT.......INTRAOPERATIVE X-RAY VERIFIED GOOD PLACEMENT OF THE HARDWARE... ...ATTENTION WAS TURNED TO DECOMPRESSION........AT THIS POINT IN TIME, ATTENTION TURNED TO THE ARTHRODESIS APPEARED MASTER GRAFT COMPRESSION RESISTANT MATRIX WAS WRAPPED IN RHBMP-2/ACS SPONGE AND AUGMENTED WITH LOCAL MORSELIZED BONE GRAFT AND CANCELLOUS CHIPS. THIS WAS PLACED IN LATERAL GUTTERS, SPANNING THE DECORTICATED TRANSVERSE PROCESSES OF L3, L4 AND L5 BILATERALLY. THE DECORTICATED FACET JOINTS WERE PACKED WITH A SMALL INFUSE SPONGE AND AUGMENTED WITH CANCELLOUS CHIPS AND LOCAL MORSELIZED BONE GRAFT. THIS COMPLETED BILATERALLY. A PRE-BENT LORDOTIC ROD WAS PLACED SPANNING THE TULIP HEADS OF THE L3, L4, AND L5 PEDICLES. THE CAPS WERE PLACED AND TIGHTENED. THEY WERE SHEARED OFF WITH A TORQUE/ANTI-TORQUE DEVICE....." NO COMPLICATIONS WERE NOTED ON (B)(6) 2012 THE PATIENT WAS ADMITTED THROUGH ER AND THEN UNDERWENT A SURGICAL PROCEDURE FOR POST-OPERATIVE WOUND DRAINAGE, LUMBAR (S UBFACSIAL) IRRIGATION AND DEBRIDEMENT FOR WOUND DRAINAGE. THESE "FINDINGS ARE CONSISTENT WITH A LIQUEFIED HEMATOMA". CULTURES WERE TAKEN. NO COMPLICATIONS WERE NOTED. ON (B)(6) 2012 THE PATIENT PRESENTED LOWER BACK PAIN AND NECK PAIN WITH SPINE TENDERNESS, REDUCED ROM, PAIN RADIATING BILATERALLY INTO LEGS AND PAIN IN MOTION. THE DOCTOR LISTED DEGENERATION OF LUMBAR OR LUMBOSACRAL INTERVERTEBRAL HERNIATED LUMBAR DISC; LUMBAR RADICULOPATHY, LUMBOSACRAL SPONDYLOSIS WITHOUT MYELOPATHY AND POST LAMINECTOMY SYNDROME OF LUMBAR REGION. ON (B)(6) 2012 IN OV'S THE PATIENT PRESENTED LOWER BACK PAIN AND NECK PAIN WITH SPINE TENDERNESS, REDUCED ROM, PAIN RADIATING BILATERALLY INTO LEGS AND PAIN IN MOTION. ON (B)(6) 2012 IN AN OV THE PATIENT PRESENTED LOWER BACK AND NECK PAIN, POST LAMINECTOMY SYNDROME OF LUMBAR REGION, LUMBAR RADICULOPATHY, RIGHT RADICULAR PAIN W/MUSCLE SPASMS IN FEET <(>&<)> TOES. ON (B)(6) 2012 THE PATIENT PRESENTED LOWER BACK PAIN AND NECK PAIN WITH SPINE TENDERNESS, REDUCED ROM, PAIN RADIATING BILATERALLY INTO LEGS AND PAIN IN MOTION. HE DOCTOR LISTED POST LAMINECTOMY SYNDROME OF LUMBAR REGION, LUMBAR RADICULOPATHY AND LUMBOSACRAL SPONDYLOSIS WITHOUT MYELOPATHY. ON (B)(6) 2012 THE PATIENT PRESENTED LOWER BACK PAIN AND NECK PAIN WITH SPINE TENDERNESS, REDUCED ROM, PAIN RADIATING BILATERALLY INTO LEGS AND PAIN IN MOTION. HE DOCTOR LISTED POST LAMINECTOMY SYNDROME OF LUMBAR REGION AND RADICULITIS, THORACIC OR LUMBAR. ON (B)(6) 2013 THE PATIENT PRESENTED BACK AND LEG PAIN, DECREASED ROM, AND TENDERNESS AND SWELLING ON THEIR BACK. THE PAIN WAS CONSTANT SHARP, DULL, THROBBING, DEEP ACHE, WHICH RADIATED TO BILATERAL LEGS AND BILATERAL ARMS. THIS IS ALSO ASSOCIATED WITH NUMBNESS AND PARESTHESIAS. THE PATIENT ALSO PRESENTED A BULGE ON HIS LOWER BACK LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243330 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M111108AAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R