INFUSE BONE GRAFT

Report

Report Number: 1030489-2012-01936
Event Type: Injury
Date Received: October 23, 2012
Report Date: November 30, 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).

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.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT TRANSFORAMINAL LUMBAR INTERBODY FUSION FOR L5/S1 LUMBAR SPONDYLOSIS, L5/S1 LUMBAR FORAMINAL STENOSIS, L5/S1 LUMBAR FACET HYPERTROPHY USING AUTOGRAFT AND RHBMP-2/ACS WITH AN INTERBODY DEVICE AND BILATERAL POSTERIOR INSTRUMENTATION (SCREWS AND RODS). ONE DAY POST-OP, FRONTAL AND LATERAL IMAGING DEMONSTRATED POSTERIOR FUSION AT L5/S1 BY SCREWS AND STABILIZATION BARS. PEDICLES ARE INTACT AND THERE WAS NO COMPRESSION DEFORMITY. AT 23 DAYS POST-OP, THE PATIENT WAS SEEN FOR FOLLOW UP. LUMBAR IMAGING SHOWED INSTRUMENTATION REMAINED IN GOOD ANATOMICAL ALIGNMENT. NO CHANGE IN POSITION OF SURGICAL HARDWARE. AT 56 DAYS POST-OP, LUMBAR IMAGING SHOWED NO SURGICAL CHANGE IN POSTERIOR FUSION. HARDWARE AND PEDICLES INTACT. AT 61 DAYS POST-OP, THE PATIENT WAS SEEN FOR OFFICE VISIT FOLLOW UP. LUMBAR X-RAYS DEMONSTRATE SATISFACTORY APPEARANCE OF INTERBODY AND INSTRUMENTATION. AT 101 DAYS POST-OP, THE PATIENT WAS SEEN FOR EVALUATION. PATIENT COMPLAINED OF PAIN. LUMBAR FILMS TAKEN NEXT DAY SHOW ALIGNMENT OF FUSED LEVEL IS MAINTAINED AND STABLE. NO ACUTE FRACTURE WAS IDENTIFIED. AT 103 DAYS POST-OP, THE PATIENT WAS SEEN FOR FOLLOW UP. PATIENT COMPLAINED HAS A LOT OF PAIN IN HER LOWER BACK. X-RAYS DEMONSTRATED SATISFACTORY APPEARANCE OF INTERBODY DEVICE AND INSTRUMENTATION. AN EVALUATION SUMMARY DATED 110 DAYS POST-OP STATED PATIENT HAS CHRONIC BACK PAIN THAT INITIALLY EXTENDED DOWN LEG SECONDARY TO RIGHT SIDE DISC PROTRUSION AT L5/S1. PATIENT SUBSEQUENTLY HAD TWO DISCECTOMIES AND RECURRENT PAIN. PATIENT HAD TLIF AT L5/S1. BACK PAIN HAD GRADUALLY IMPROVED. PAIN WAS CENTRAL IN LOCATION AND DID NOT RADIATE INTO BUTTOCKS OR DOWN LEGS. THERE WAS NO ASSOCIATED WEAKNESS OR NUMBNESS IN EXTREMITIES. 138 DAYS POST-OP, THE PATIENT CHANGED DOCTORS. THE PATIENT PRESENTED TO THE NEW PHYSICIAN WITH CHRONIC PAIN. NO NEW WEAKNESS OR NUMBNESS WAS NOTED. PATIENT REQUESTED AN INCREASE IN PAIN MEDICATION. AT 197 DAYS POST-OP, THE PATIENT UNDERWENT A LUMBAR MRI. MRI SHOWED EVIDENCE OF INTERBODY GRAFT MATERIAL. SOME NARROWING OF RIGHT NEURAL FORAMINA AS DEGENERATIVE DISC CHANGES ARE SLIGHTLY MORE PRONOUNCED. NO EVIDENCE OF RECURRENT DISC HERNIATION. AT 211 DAYS POST-OP, THE PATIENT WAS SEEN FOR FOLLOW UP. PATIENT COMPLAINED OF CHRONIC BACK PAIN. THE PATIENT UNDERWENT MRI SCAN. AT 232 DAYS POST-OP, THE PATIENT WAS SEEN FOR FOLLOW UP. PATIENT PRESENTED WITH PAIN SECONDARY TO DISC HERNIATION. X-RAYS REVIEWED 245 DAYS POST-OP SHOWED INTERBODY GRAFT IN APPROPRIATE PLACE AT L5/S1 WITH BILATERAL PEDICLE SCREW INSTRUMENTATION WHICH SHOWS NO SIGNS OF LOOSENING. NO OBVIOUS SIGN OF INTERBODY FUSION. MAY BE SOME SLIGHT ANTERIOR SHADOWING IN FAR ANTERIOR ANNULUS AT L5/S1 281 DAYS POST-OP, THE PATIENT UNDERWENT LUMBAR CT SCAN. CT SHOWED ANTERIOR AND POSTERIOR FUSION AT L5/S1 WITH EXTRUDED GRAFT MATERIAL OR BONE FORMATION RELATED TO RIGHT FACETECTOMY WITH RIGHT CENTRAL LOCATION BRIDGING L5 VERTEBRAL BODY AND RIGHT LATERAL MASS OF S1. NO RESIDUAL STENOSIS. MILD FACET DEGENERATIVE CHANGES AT L3/4 AND L4/5 WITH A MINIMAL DISC BULGE AT L4/5. 353 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. CT SCAN SHOWED INTERBODY FUSION WAS SOLID. THERE MAY BE SLIGHT HALO EFFECT AROUND RIGHT L5 SCREW. PATIENT HAS HETEROTOPIC BONE, ALMOST CYSTIC TYPE APPEARANCE, WITH SIGNIFICANT FORAMINAL NARROWING CAUSING COMPRESSION OF FIFTH ROOT: PATIENT HAS SOME WEAKNESS IN L5 DISTRIBUTION AND MODERATE SEVERE BACK PAIN. AT 392 DAYS POST-OP, THE PATIENT WAS ADMITTED TO HOSPITAL FOR LUMBAR DIS DISRUPTION WITH SPINAL STENOSIS. PATIENT COMPLAINED OF RIGHT SIDE LOW BACK PAIN, BUTTOCK, HIP AND LEG PAIN GREATER THAN THE LEFT LEG. PATIENT UNDERWENT REMOVAL OF HARDWARE, REDO LAMINECTOMY AND POSSIBLE FUSION. PATIENT HAS SIGNIFICANT PAIN IN RIGHT LEG WITH SI TYPE SYMPTOMS WITH HETEROTOPIC OSSIFICATION. SIGNIFICANT COMPRESSION OF S1 AND L5 ROOTS WITH HETEROTOPIC CLASSIFICATION LOCATED INTO THE BASE OF NERVE ROOTS. FUSION WAS SOLID. PATIENT SHOWED GOOD PROGRESS POST-OP. AT 393 DAYS POST-OP, THE PATIENT UNDERWENT OCCUPATIONAL THERAPY. PATIENT REPORTED LE PRE-OP PAIN WAS SEVERE; LE POST OP PAIN WAS NUMBNESS IN RIGHT LEG. PATIENT STATED "I NEED PAIN MEDICINE; MY RIGHT LEG HURTS TO MUCH TO WALK." AT 407 DAYS POST-OP, OFFICE VISITS NOTES STATED THAT THE PATIENT HAD DURAL LEAK. PATIENT HAD EXTREME RIGHT LEG PAIN. IT IS VERY SENSITIVE AND BURNING PAIN TO TOUCH. NO SWELLING. LUMBAR FILMS SHOW GOOD POSITIONING OF PREVIOUS IMPLANT AT L5/S1. EVIDENCE OF UNILATERAL HARDWARE REMOVAL ON RIGHT SIDE. AT 418 DAYS POST-OP, AN MRI DEMONSTRATED PRESENCE OF SOME HIGH SIGNAL POTENTIALLY CONSISTENT WITH PSEUDOMENINGOCELE VERSUS CSF VERSUS SEROMA MASS EFFECT ON NERVE ROOT. PATIENT HAS SOME SLIGHT L5 WEAKNESS AND SOME SIGNIFICANT OVERGROWTH OF FUSION MASS. A LOT OF COMPRESSION AGAINST NERVE ROOT. PATIENT UNDERWENT RIGHT L5 TRANSFORAMINAL EPIDURAL STEROID INJECTION. AT 424 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP STATUS POST INJECTION. INJECTION HELPED WITH SEVERE PAIN. NO WORSENING FOCAL NEUROLOGIC DEFICITS IDENTIFIED. LEG PAIN STILL PRESENT AND STILL DEBILITATING. MRI IS CONSISTENT WITH WHAT WAS MOST LIKELY A PSEUDO MENINGOCELE. AT 438 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. PATIENT CONTINUED TO HAVE SOME PAIN RADIATING INTO HER RIGHT LEG IN L5. PATIENT HAD ANTALGIC GAIT AND HAS LIMITED RANGE OF MOTION OF LUMBAR SPINE. PAIN RADIATED INTO L5 DISTRIBUTION WITH NUMBNESS. AT 453 DAYS POST-OP, THE PATIENT UNDERWENT RIGHT L5 AND S1 TRANSFORAMINAL EPIDURAL STEROID INJECTIONS. AT 473 DAYS POST-OP, THE PATIENT PRESENTED FOR A FOUR WEEK FOLLOW UP VISIT. X-RAYS SHOW APPROPRIATE POSITION OF INSTRUMENTATION AND INTERBODY AT L5/S1. NOTED IMPROVEMENT IN RIGHT LEG PAIN. PATIENT UNDERWENT RIGHT L5 AND S1 TRANSFORAMINAL EPIDURAL STEROID INJECTION. AT 515 DAYS POST-OP, THE PATIENT PRESENTED FOR SIX WEEK FOLLOW UP STATUS POST HARDWARE REMOVAL. PATIENT HAS EXTREME RIGHT LEG NUMBNESS. LEFT LEG STARTING TO BECOME BOTHERSOME WITH BURNING SENSATION TO TOP OF SHINS. LUMBAR FILMS SHOW GOOD POSITION OF PEEK IMPLANTS. EVIDENCE OF FUSION. AT 522 DAYS POST-OP, THE PATIENT HAD ABNORMAL EMG STUDY. THERE WAS EVIDENCE OF MILD CHRONIC L5 LUMBAR RADICULOPATHY. PATIENT UNDERWENT RIGHT L5 AND S1 EPIDURAL INJECTION. POST-OPERATIVELY, IT IS ALLEGED THAT THE PATIENT DEVELOPED SEVERE NERVE DAMAGE, COMPLETE BEDREST FOR THREE MONTHS, NUMBNESS IN LEGS, UNCONTROLLED BONE GROWTH, AND A DURAL TEAR (SPINAL LEAK) DUE TO PRESSURE FROM BONE OVERGROWTH.

Description of Event or Problem · 1

IT WAS REPORTED THAT ON (B)(6) 2011, PATIENT UNDERWENT FOLLOWING PROCEDURE: RIGHT TRANSFORAMINAL LUMBAR INTERBODY FUSION. DECOMPRESSION: 1. RIGHT L5-S1 COMPLETE FACETECTOMY, RIGHT L5-S1 COMPLETE DISCECTOMY, RIGHT L5-S1 PARTIAL HEMILAMINECTOMY TO DECOMPRESS THE EXITING AND PASSING NERVE ROOT, 2. COMPLETE LUMBAR DISCECTOMY, L5-S1, WITH ENDPLATE REMOVAL FOR PREPARATION OF THE ENDPLATE FOR ARTHRODESIS; ARTHRODESIS: 1. RIGHT L5-S1 TRANSFORAMINAL APPROACH FOR ARTHRODESIS IN THE INTERBODY SPACE USING A COMBINATION OF LOCALLY HARVESTED AUTOGRAFT AND BMP SOAKED COLLAGE SPONGE. 2. HARVEST OF LOCAL AUTOGRAFT DURING DECOMPRESSION. INSTRUMENTATION: 1. BILATERAL PEDICLE SCREW INSTRUMENTATION, L5-S1, USING SCREW SYSTEM AND DUAL TITANIUM RODS FOR AN ALL TITANIUM CONSTRUCT. 2. RIGHT APPROACH FOR TRANSFORAMINAL PLACEMENT OF INTERBODY DEVICE USING A CAGE DEVICE. 3. INTRAOPERATIVE FLUOROSCOPY IN BOTH AP AND LATERAL MODES THROUGHOUT THE PROCEDURE. NEUROLOGIC MONITORING: 1. FREE-RUN EMG OF EXITING AND PASSING NERVE ROOT DURING THIS PROCEDURE CONTINUOUSLY. 2. INTRAOPERATIVE STIMULATION OF NERVE ROTS BILATERALLY AT THIS LEVEL USING STIMULATION OF THE PAK NEEDLES AND THE TAP. 3. INTRAOPERATIVE INTERPRETATION OF THE DATA; FOR PRE-OP DIAGNOSIS OF: LUMBAR SPONDYLOSIS, L5-S1, LUMBAR FORAMINAL STENOSIS, L5-S1, LUMBAR FACET HYPERTROPHY, L5-S1. PER-OP NOTES: DISC MATERIAL WAS REMOVED. A TEMPLATE WAS USED TO IDENTIFY THE SIZE OF CAPSTONE DEVICE. LOCALLY HARVESTED BONE GRAFT WHICH WAS COLLECTED DURING DECOMPRESSION, WAS ROLLED INTO AN RHBMP-2 SOAKED COLLAGEN SPONGE. SPONGES WERE PLACED IN DISC SPACE. INTERBODY DEVICE WAS PLACED INTO DISC SPACE, TAMPED INTO DISC SPACE, COUNTERSUNK APPROPRIATELY, AND THEN APPROPRIATELY POSITIONED. CONSTRUCTS WERE APPROPRIATELY POSITIONED AND SET SCREWS WERE TIGHTENED TO APPROPRIATE TORQUE. NO COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFUSE BONE GRAFT	FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET	NEK	MEDTRONIC SOFAMOR DANEK USA, INC	NA	M110911AAL

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention