BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3965209 · Received July 29, 2014

    Report

    Report Number
    1030489-2014-03344
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    April 14, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. 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

    ADDITIONAL INFORMATION: (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2008 CERVICAL X-RAYS MULTIPLE FILMS OF THE CERVICAL SPINE SHOW NORMAL LORDOSIS WITH VERY SLIGHT C3/4 DISC NARROWING. OBLIQUES SHOW OPEN FORAMINA. ODONTOID APPEARS NORMAL. LUMBAR X-RAYS MULTIPLE VIEWS INCLUDING AP, LATERAL AND OBLIQUES SHOW MODERATE DJD AT L4. ALIGNMENT IS NORMAL WITHOUT EVIDENCE OF TRAUMA. PELVIC X-RAYS SACROILIACS, HIPS AND PUBIS APPEAR NORMAL. DEGENERATION AT L4 IS NOTED BY SCLEROSIS AND IRREGULARITIES IN THE ENDPLATES OF L4 AND L5. JOINT SURFACES IN BOTH WEIGHT BEARING DOMES ARE SLIGHTLY NARROWED, BUT THERE IS NO SCLEROSIS, CYSTS OR OSTEOPHYTES TO SUGGEST BONY REACTION TO ABNORMAL LOADING. HIP X-RAYS AP AND FROG LEG VIEWS ARE COMPLETELY WITHIN NORMAL LIMITS. NECK /SHAFT ANGLE IS NORMAL, BONY COVERAGE IS NORMAL. VERY MINIMAL NARROWING OF THE JOINT SPACE ACROSS BOTH WEIGHT BEARING DOMES AS WAS SEEN ON THE PELVIC FILM. RIGHT KNEE X-RAYS AP, LATERAL AND OBLIQUE FILMS APPEAR TO SHOW NORMAL ALIGNMENT OF FEMUR, TIBIA, AND PATELLA. NO JOINT SPACE NARROWING. NO EVIDENCE OF TRAUMA OR TUMOR. CERVICAL SPINE SERIES SINGLE CROSS TABLE LATERAL APPEARS NORMAL WITH THE EXCEPTION OF MINIMAL POSTERIOR SUBLUXATION OF C3 ON C4 AND VERY EARLY DISC ARTHRITIS WITH SCLEROSIS AND NARROWING AT C7/T1 LUMBAR SPINE X-RAYS TWO LATERAL VIEWS AGAIN SHOW MODERATE DEGENERATIVE COLLAPSE AND SCLEROSIS ACROSS L4/5. STUDY IS OTHERWISE NORMAL. ON (B)(6) 2010 LUMBAR MRI STIR SAGITTAL VIEWS SHOW DISC DESICCATION AT L5 UP THROUGH L1. THERE IS BONY EDEMA ON EITHER SIDE OF THE L4 DISC THAT INCLUDES MOST OF THE L4 AND L5 BODIES. DISC BULGING IS PRESENT AT ALL DEGENERATIVE LEVELS, BUT DOES NOT APPEAR TO SHOW STENOSIS EXCEPT AT L4. AXIAL VIEWS CONFIRM MINOR FORAMINAL NARROWING ON THE LEFT AT L4. NO SIGNIFICANT CENTRAL STENOSIS IS PRESENT IN THIS SERIES. CERVICAL MRI SAGITTAL T2 IMAGES SHOW MINOR BULGING OF DISCS AT C5/6, C6/7 AND C7/T1. NO STENOSIS IS PRESENT. DISC DESICCATION IS NOTED AT ALL CERVICAL LEVELS. AXIAL VIEWS VERIFY NO SIGNIFICANT SPINAL STENOSIS, HNP OR FORAMINAL NARROWING IS NOTED. ON (B)(6) 2010 LUMBAR CT NO CHANGE IN POSITION OF IMPLANTS IS NOTED. LEFT L5 SCREW MISSES THE PEDICLE AND EXTENDS INTO THE REGION OF THE L4 ROOT. THE RIGHT L5 SCREW APPEARS TO PENETRATE MEDIAL PEDICLE WALL AND ENTER THE CANAL. FUSION NOW APPEARS SOLID. LEFT L5 LAMINECTOMY IS AGAIN SEEN AND NO EVIDENCE OF HETEROTOPIC BONE IS APPRECIATED ON THESE STUDIES. ON (B)(6) 2010 CHEST X-RAYS PA AND LATERAL VIEWS SHOW NORMAL CARDIAC, PULMONARY AND BONY RELATIONSHIPS. LATERAL OF THORACIC SPINE SHOWS SLIGHT LOSS OF LORDOSIS BUT WITHIN THE RANGE OF NORMAL. ON (B)(6) 2010 LUMBAR SPINE SERIES INITIAL LATERAL LUMBAR VIEW SHOWS LOCALIZATION PROBE AT L4/5 JUST CAUDAL TO THE UPPER ASPECT OF THE L5 PEDICLE. SUBSEQUENT LATERAL VIEWS SHOW SCREWS IN PLACE BILATERALLY AT L4 AND L5. A SECOND VIEW WITH RODS IN PLACE APPEARS TO SHOW ONE SCREW IN THE L4 DISC SPACE HOWEVER WITHOUT ACCOMPANYING AP THIS CANNOT BE DETERMINED. ON (B)(6) 2010 LUMBAR CT SHOWS SCREWS AND SPACER SPANNING THE L4/5 LEVEL. L5 SCREW POSITION IS PROBLEMATIC. THE RIGHT SCREW APPEARS TO PENETRATE THE MEDIAL CORTICAL WALL OF THE PEDICLE, IMPINGING UPON THE RIGHT L5 ROOT. THE LEFT SCREW HAS BEEN REPOSITIONED WITH INITIAL TRAJECTORY WITHIN THE PEDICLE NOTED BY THE BONY SCAR, THE NEW AND CURRENT TRAJECTORY TAKES IT THROUGH THE TRANSVERSE PROCESS THEN LATERAL TO THE PEDICLE AND VERTEBRAL BODY. L4 POSITION IS SATISFACTORY. SPACER IS IN GOOD POSITION. LEFT SIDED LAMINECTOMY HAS BEEN PERFORMED ADJACENT TO THE L4/5 DISC. ON (B)(6) 2010 VENOUS DUPLEX DOPPLER NO SPINAL PATHOLOGY IDENTIFIED. ON (B)(6) 2010 LUMBAR CT SHOWS SCREWS AND SPACER SPANNING THE L4/5 LEVEL. L5 SCREW POSITION IS PROBLEMATIC. THE RIGHT SCREW APPEARS TO PENETRATE THE MEDIAL CORTICAL WALL OF THE PEDICLE, IMPINGING UPON THE RIGHT L5 ROOT. THE LEFT SCREW HAS BEEN REPOSITIONED WITH INITIAL TRAJECTORY WITHIN THE PEDICLE NOTED BY THE BONY SCAR, THE NEW AND CURRENT TRAJECTORY TAKES IT THROUGH THE TRANSVERSE PROCESS THEN LATERAL TO THE PEDICLE AND VERTEBRAL BODY. L4 POSITION IS SATISFACTORY. SPACER IS IN GOOD POSITION. LEFT SIDED LAMINECTOMY HAS BEEN PERFORMED ADJACENT TO THE L4/5 DISC. SAGITTAL RECONSTRUCTIONS CANNOT VERIFY SOLID FUSION. PEDICLE SCREWS ARE POORLY POSITIONED AS NOTED ON AXIAL VIEWS. ON (B)(6) 2011 CERVICAL CT AXIAL VIEWS ARE VERY CLEAR. SOME ARTHRITIC NARROWING IS NOTE ON THE LEFT AT C6 AN IN THE C4/5 FORAMEN ON THE LEFT ALTHOUGH IT IS NOT SEVERE ENOUGH TO CAUSE NERVE COMPRESSION. THESE NON-CONTRASTED VIEWS DO NOT SHOW CANAL CONTENTS CLEARLY.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION AT L4-L5 IN WHICH A PEEK INTERBODY CAGE AND RHBMP-2/ACS WERE USED. THE CAGE WAS PACKED WITH BMP. REPORTEDLY, FOLLOWING HIS SURGERY, THE PATIENT INITIALLY IMPROVED, BUT SUBSEQUENTLY DEVELOPED ADDITIONAL, NEW AND/OR WORSE PAIN, SUFFERING, SYMPTOMS AND DISABILITY. SPECIFICALLY, PATIENT HAS EXPERIENCED PROGRESSIVE, DISABLING PAIN IN HIS LOWER BACK, RADIATING TO HIS LEGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON, (B)(6) 2013, (B)(6) 2014 PATIENT PRESENTED WITH NECK, BACK AND LEG PAIN. (B)(6) 2014 PATIENT PRESENTED WITH NECK, BACK AND LEG PAIN. (B)(6) 2015 PATIENT PRESENTED WITH NECK BACK AND LEG PAIN. (B)(6) 2014, (B)(6) 2015 PATIENT PRESENTED WITH NECK, LBP, LEG AND FOOT PAIN. (B)(6) 2015 PATIENT FOR AN OFFICE VISIT DUE TO THE FOLLOWING : DDD L5-S1, DDD C3-4, IDD C2-7, POST LAMINECTOMY L4-5, PERIPHERAL NEUROPATHY, SPINAL STENOSIS L2-3, L3-4. PATIENT UNDERWENT CT OF LUMBAR SPINE WITHOUT CONTRAST. IMPRESSION: 1. POSTSURGICAL CHANGE WITH METALLIC FIXATION HARDWARE AT THE L4-5 LEVEL WITH THE LEFT PEDICLE SCREW AT L5 EXTENDING INTO THE SOFT TISSUES BETWEEN THE L5 VERTEBRAL BODY AND THE LEFT PSOAS MUSCLE, 2. THERE WAS NO ACUTE FRACTURE3. MILD DISC BULGING AND OSTEOPHYTE FORMATION AT L3-L4 AND L5-S1

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011: PATIENT PRESENTED FOR OFFICE VISIT FOR CONTINUED FOLLOW UP TREATMENT RELATED TO CHRONIC PAIN. ASSESSMENT: LUMBAR FUSION (B)(6) 2010; C6 RADICULOPATHY; NEURAL ENCROACHMENT C5-6; LUMBAGO, LUMBAR DISCITIS; INSOMNIA, CHRONIC PAIN SYNDROME, HX: DEEP VEIN THROMBOSIS (DVT) LOWER EXTREMITY. (B)(6) 2012: PATIENT PRESENTED FOR OFFICE VISIT FOR CONTINUED FOLLOW UP TREATMENT RELATED TO CHRONIC PAIN. ASSESSMENT: LUMBAR FUSION (B)(6) 2010; C6 RADICULOPATHY; NEURAL ENCROACHMENT C5-6; LUMBAGO, LUMBAR DISCITIS; INSOMNIA, CHRONIC PAIN SYNDROME, HX: DEEP VEIN THROMBOSIS (DVT) LOWER EXTREMITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442251 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110812AAO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other