BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 6197745 · Received December 22, 2016

    Report

    Report Number
    1030489-2016-03471
    Event Type
    Injury
    Date Received
    December 22, 2016
    Report Date
    October 27, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2007, PATIENT WAS ADMITTED TO THE FACILITY, WHERE THE SURGEON PERFORMED SPINE FUSION SURGERY INVOLVING RHBMP2 THE LUMBAR REGION OF HIS SPINE FROM VERTEBRAE L3 TO S1. THE RHBMP-2 COLLAGEN SPONGE WAS USED TO FUSE MORE THAN ONE LEVEL OF THE SPINE. THE RHBMP-2 COLLAGEN SPONGE WAS PLACED OUTSIDE A CAGE (I.E., IN THE DISC SPACE). POST-OP, PATIENT REPORTED "PROGRESSIVELY INCREASING LOW BACK PAIN AND RADICULAR SYMPTOMS IN HIS LOWER EXTREMITIES. PATIENT CONTINUES TO EXPERIENCE CHRONIC AND EXTREME PAIN AND MUSCLE SPASMS IN HIS LOWER BACK, RADIATING PAIN DOWN HIS RIGHT LEG, NUMBNESS IN HIS LEFT LEG, AND NUMBNESS IN BOTH FEET. PATIENT WAS UNABLE TO WALK EXTENDED DISTANCES, AND SUFFERS FROM BOWEL AND SEXUAL DYSFUNCTION"

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2007: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LEFT-SIDED L3-L4 FAR LATERAL AND LEFT-SIDED L4-L5 POSTEROLATERAL DISC HERNIATIONS WITH L3, L4, AND L5 LEFT-SIDED RADICULOPATHY, SPINAL INSTABILITY AND UNDERWENT THE FOLLOWING PROCEDURES: LEFT-SIDED L3, L4, AND L5 LUMBAR LAMINECTOMIES WITH COMPLETE FACETECTOMIES. SPINAL INSTRUMENTATION (PEDICLE SCREWS AT L3,L4, L5, AND S1 LEVELS.) ARTHRODESIS, TRANSFORAMINAL LUMBAR INTERBODY TECHNIQUE IN THE INTERVERTEBRAL SPACES OF L3-L4, L4-L5, AND L5-S1. APPLICATION OF BIOMECHANICAL INTERVERTEBRAL DEVICES AT L3-L4, L4-L5, AND L5-S1 (PEEK CAGES). ARTHRODESIS POSTERIOR LATERAL TECHNIQUE FROM L3 TO S1. INTRAOPERATIVE FLUOROSCOPY. PRE-OPERATIVELY, MRI SHOWED A SIGNIFICANT L4-L5 POSTERIOR LATERAL DISC HERNIATION ON THE LEFT SIDE WITH COMPRESSION OF L4 AND L5 NERVE ROOTS. THE PATIENT ALSO HAD PREVIOUS L5 LEFT LAMINOTOMY FOR AN ACUTE HERNIATED DISC SUPPOSEDLY AT L5-S1 IN ACCORDANCE WITH THE PATIENT, BUT, NO RECORDS COULD BE OBTAINED. AS PER THE OPERATIVE NOTES ".. UPON PLACEMENT OF THE SCREWS WE PERFORMED TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L3-L4, L4-L5, AND L5-S1 LEVELS ON THE LEFT SIDE. THE NERVE ROOTS WERE DISSECTED AND PROTECTED USING LOVE RETRACTOR OF THESE DISKS WERE OPENED USING 11-BLADE SCALPEL AND COMPLETE DISCECTOMIES WERE PERFORMED USING TRANSFORAMINAL LUMBAR INTERBODY FUSION INSTRUMENTS. GOOD END-PLATE PREPARATION WAS ACHIEVED USING CURETTES AND WE PLACED 12 X 26MM PEEK CAGE INTO THE INTERSPACE OF L3-L4, PEEK CAGE INTO THE INTERSPACE L4-L5 AND ANOTHER PEEK 12X 26 MM CAGE INTO THE INTERSPACE L5-S1 INTERSPACE. PRIOR TO PLACEMENT OF THE CAGES WE PACKED THE INTERSPACES WITH PATIENT'S OWN BONE OBTAINED FROM THE LAMINA AND MIXED WITH BMP SPONGES. WE ALSO INSERTED BMP SPONGE WITH A PIECE OF BONE WITHIN EACH CAGE. UPON PLACEMENT OF THE CAGES AGAIN FLUOROSCOPY WAS PERFORMED. WE ENSURED GOOD POSITION OF THE CAGES, 90MM RODS WERE PLACED INTO THE TULIPS OF THE PEDICLE SCREWS, COMPRESSION WAS APPLIED SEQUENTIALLY AND BILATERALLY AND ANOTHER X-RAY WAS PERFORMED TO CONFIRM GOOD LORDOSIS AND GOOD LOCK OF THE CAGES IN THE POSITION.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850733 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110606AAJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other