INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2013-02430
- Event Type
- Injury
- Date Received
- June 20, 2013
- Report Date
- June 14, 2016
- 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
(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.
(B)(4).
(B)(4).
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.
IT WAS REPORTED THAT ON (B)(6) 2009 THE PATIENT PRESENTED WITH THE PREOPERATIVE DIAGNOSIS OF DISCOGENIC PAIN L2-L3 AND L3-L4 AND MILD SCOLIOSIS ABOVE THE FUSIONS AND RETROLISTHESIS AT L2-L3. THE PATIENT UNDERWENT SURGERY WHICH CONSISTED OF LATERAL EXTRAPERITONEAL APPROACH TO L2-L3 AND L3-L5 DISKS; ANTERIOR ARTHRODESIS L2-L3 AND L3-L4 WITH INFUSE AND FORTROSS; INSERTION OF PROSTHESIS PEEK SPACERS, 18X45X13 AT L2-L3 AND 18X50X13 AT L3-4 WITH CROSS-FUSE PROSTHESIS. PER THE OPERATIVE REPORT ¿¿ (L2-3) I SELECTED AN APPROPRIATE 18 X13 AND I MEASURED OUT 45, THE SPACER WAS THEN TAKEN AND FILLED WITH INFUSE AND THEN INSERTED UNDER IMAGE CONTROL¿.I FINALLY SELECTED AN 18X50X13. I FILLED THE SPACER AGAIN WITH INFUSE BUT ALSO WITH FORTROSS THAT WAS MIXED WITH BLOOD FROM THE INTERSPACE AND THEN INSERTED UNDER IMAGE CONTROL¿¿ THE PATIENT ALSO UNDERWENT A SECOND STAGE PROCEDURE TO THE INITIAL LATERAL INTERBODY FUSION WHICH CONSISTED OF SEGMENTAL INSTRUMENTATION L2-L3,L3-L4 BILATERALLY AND POSTEROLATERAL INTRATRANVERSE PROCESS FUSION L2-L4 BILATERALLY WITH FORTROSS. NO PATIENT COMPLICATIONS WERE NOTED IN EITHER PROCEDURE. POST-OPERATIVE ANEMIA WAS REPORTED. ON (B)(6) 2009 THE PATIENT WAS DISCHARGED FORM HOSPITAL. ON (B)(6) 2010 THE PATIENT PRESENTED WITH BACK AND UNDERWENT A HELICAL CT OF THE LUMBAR SPINE WHICH SHOWED A BORDERLINE ABDOMINAL AORTIC ANEURYSM (2.8 CM); POST-SURGICAL CHANGES TO LUMBAR SPINE WITH PRESERVATION OF ALIGNMENT; AND EXTENSIVE DENSE MATERIAL POSTERIOR TO THE PEDICLE SCREWS AT L2-L4 LEVELS, WHICH MAY HAVE REPRESENTED MINERALIZATION/OSSIFICATION. ON (B)(6) 2010 THE PATIENT COMPLAINED OF CONSTANT BACK AND HIP PAIN WITH DIFFICULTY WALKING, LIFTING, STANDING AND SLEEPING. THE PATIENT COMPLAINED OF BEING ANXIOUS, IRRITABLE, AND DEPRESSED DUE TO THE PAIN. ON (B)(6) 2010 THE PATIENT PRESENTED WITH HIP PAIN AND RIGHT KNEE PAIN (REPORT MENTIONS A HISTORY OF FALLS) AND UNDERWENT A PELVIS X-RAY WHICH DEMONSTRATED NO FRACTURE OR MISS-ALIGNMENT; MILD ARTHRITIC CHANGES OF THE HIPS AND LOWER SACROILIAC JOINTS; AND CALCIFIC TENDONITIS INVOLVING THE GREATER TROCHANTERIC INSERTION SITE ON THE RIGHT. THE PATIENT ALSO UNDERWENT A MRI OF THE RIGHT KNEE WHICH SHOWED A COMPLEX TEAR INVOLVING THE ANTERIOR HORN OF THE LATERAL MENISCUS EXTENDING LATERALLY, ANTERIORLY TO THE SUPERIOR ARTICULAR SURFACE AND THE BODY OF THE LATERAL MENISCUS AS WELL. A MRI OF THE HIPS /LIMITED PELVIS SHOWED INTERVAL DISC CAGES AT L4-L5 AND L5-S1; NO EVIDENCE OF INGUINAL OR EXTERNAL ILIAC ADENOPATHY; NO OBVIOUS OSTEOARTHRITIS INVOLVING THE HIPS WITH THE EXCEPTION OF A MILD ARTICULAR CARTILAGE LOSS SUPERIORLY; SYMMETRICAL AND PROBABLE PHYSIOLOGICAL AMOUNT OF SMALL FLUID WITHIN BOTH HIP JOINTS. ON (B)(6) 2010 AND (B)(6) 2010 THE PATIENT COMPLAINED OF BACK PAIN. ON (B)(6) 2010 THE PATIENT PRESENTED WITH SEVERE BACK PAIN AND UNDERWENT A MRI OF THE LUMBAR SPINE WHICH DEMONSTRATED NO FRACTURE OR MISALIGNMENT; NO SIGNIFICANT SPINAL STENOSIS; VARIABLE MILD INFERIOR FORAMINAL NARROWING WAS NOTED AT L2-L3, L3-L4, AND L4-L5 AND MILD OR MILD TO MODERATE FACET ARTHROPATHY AT L1-L2, L2-L3, L3-L4, AND L4-L5. ON (B)(6) 2010 THE PATIENT PRESENTED SEVERE BACK PAIN WORSE WITH WALKING, BENDING, AND STANDING. ON (B)(6) 2010 THE PATIENT PRESENTED LOW BACK PAIN. A CT DISCOGRAM OF THE LUMBAR SPINE WAS CONDUCTED WHICH SHOWED L1-L2 MINIMAL DEGENERATION L1-L2. THERE WAS AN ANTERIOR FUSION FROM L2 TO THE SCRUM WHICH APPEARED SOLID. THERE WAS POSTERIOR INSTRUMENTATION FROM L2 TO L4. THE FACETS AT THE L2-L4 LEVEL WERE NOT FUSED. THERE WAS NON-INCORPORATED BONE MATERIAL FROM L2 TO L4. THE BONE MATERIAL EXTENDED POSTERIORLY TO THE SUBCUTANEOUS TISSUES PARALLEL TO THE PEDICLE SCREWS. ON (B)(6) 2010 THE PATIENT COMPLAINED OF SEVERE PAIN AND NUMBNESS; THAT THEY COULDN¿T DO ANYTHING (NOTES MENTION THE PATIENT USED TO SWIM 5 MILES A DAY); THAT THEY COULDN¿T SLEEP ¿ WAKING UP EVERY HOUR; AND HAD DIFFICULTY GETTING OUT OF BED. ON (B)(6) 2011 THE PATIENT COMPLAINED OF BACK, LEG, BILATERAL FEET PAIN. THE DOCTOR¿S NOTE¿S MENTION FAILED BACK SYNDROME. ON (B)(6) 2011 THE PATIENT PRESENTED WITH LOW BACK PAIN AND UNDERWENT A HELICAL CT OF THE LUMBAR SPINE WHICH SHOWED INTACT HARDWARE WITHOUT FRACTURE OR LOOSENING; SUBSTANTIAL FACET ARTHRITIS IN THE LUMBAR SPINE; COMBINATION FACET ARTHROPATHY AND DISC BULGE CONTRIBUTING TO MILD LEVEL SPINAL CANAL STENOSIS AT L4-L5; AND MILD SUBARTICULAR RECESS NARROWING BILATERALLY AT SEVERALLEVELS. ON (B)(6) 2011 THE PATIENT PRESENTED WITH BACK AND LEG PAIN WORSE SINCE THE LAST SURGERY AND SEVERE TENDERNESS AND PAIN THROUGH THE PERCUTANEOUS INCISIONS AND SIGNIFICANT HARDENING CONSISTENT WITH CALCIFICATION DORSAL TO THE SCREWS. THE PATIENT PRESENTED THE PREOPERATIVE DIAGNOSIS OF INCOMPLETE FUSION AT L4-L5 AND L3-L4 ANTERIORLY; SEVERE PAIN ON THE RIGHT SIDE AT THE HEADS OF THE PEDICLE SCREWS PLACE PERCUTANEOUSLY; BILATERAL RADICULOPATHY, WORSE ON THE LEFT SIDE IN THE L3-4 DISTRIBUTION. THE PATIENT UNDERWENT SURGERY WHICH CONSISTED OF EXPLORATION OF THE SPINE; REMOVAL OF PEDICLE SCREWS AT L2, L3 AND L4 ON THE RIGHT SIDE; REMOVAL OF HYPERTROPHIC OSSIFICATION IN THE MUSCLES THAT OCCURRED DORSAL TO THE PEDICLE SCREWS AT L2, L3 AND L4; DORSAL LUMBAR FUSION, LAMINAE OF L3, L4 AND L5, USING THE PATIENT'S BONE AND 2.8 CUBIC CENTIMETERS OF BONE MORPHOGENIC PROTEIN; CANCELLOUS BONE ALLOGRAFT AND ACTIFUSE; EXPLORATION OF LUMBAR SPINE AT L2-3 AND L3-4 ON THE RIGHT SIDE WITH PRESERVATION OF PEDICLE SCREWS; AND L2-3, L3-4 LAMINOTOMIES, INFERIOR MEDIAL FACETECTOMIES AND DECOMPRESSION OF L3 AND L4 NERVE ROOTS ON THE LEFT SIDE. NOTE SHOULD BE MADE THAT IT WAS DECIDED NOT TO REMOVE THE SCREWS ON THE LEFT SIDE AS THE PATIENT WAS STILL LOOSE AT L3-4 AND L4-5. PER THE OPERATIVE REPORT ¿¿I WENT TO THE OTHER SIDE AND USED THE POWER DRILL AND DECORTICATED THE SPINOUS PROCESS ON THE RIGHT SIDE, AS WELL AS THE LAMINAE OF L3, L4, AND L5 ¿WE MADE A LAYER OF BONE MORPHOGENIC PROTEIN OF ABOUT 1.4, WITH THE PATENTS BONE AND CORTICAL BONE.. THEN WE PLACED ABOUT 2CC OF CORTICAL CANCELLOUS BONE WITH ACTIFUSE ON TOP¿.¿ NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2011 A BIOPSY WAS CONDUCTED OF THE REACTIVE SCAR TISSUE, BONE AND TISSUE SAMPLES FROM THE SURGERY WHICH SHOWED THAT THE SCAR TISSUE AND GRANULATIONS TISSUE WERE BENIGN AND THE BONE TISSUE UNREMARKABLE. ON (B)(6) 2011 THE PATIENT WAS DISCHARGED FROM HOSPITAL. ON (B)(6) 2011 THE PATIENT COMPLAINED OF CRAMPS DOWN THE BACK LEGS AND THE INABILITY TO SLEEP DUE TO PAIN. ON (B)(6) 2011 THE PATIENT PRESENTED WITH PAIN POST LUMBAR DECOMPRESSION AND UNDERWENT A HELICAL CT OF THE LUMBAR SPINE WHICH SHOW ED THE L2, L3, AND L4 RIGHT PEDICLE SCREWS HAD BEEN REMOVED BUT OTHERWISE NO SIGNIFICANT CHANGES ON EXAMINATION FROM PRIOR EXAMINATION. ON (B)(6) 2011 THE PATIENT COMPLAINED OF LUMBAR PAIN AND MENTIONED A RECENT FALL. ON (B)(6) 2011 THE PATIENT PRESENTED WITH LOW BACK PAIN RADIATING TO THE RIGHT GROIN WHICH THEY STATED STARTED THREE WEEKS PRIOR AFTER BENDING OVER AND BEING UNABLE TO MOVE FOR 20 MINUTES. THE PATIENT ALSO COMPLAINED OF MUSCLE SPASM IN THE RIGHT CALF AT NIGHT. THE PATIENT STATED THEY COULD FEEL A SCREW UNDER THE SKIN. A MRI OF THE LUMBAR SPINE WAS CONDUCTED WHICH SHOWED THAT THE L2, L3, AND L4 RIGHT PEDICLE SCREWS HAD BEEN REMOVED BUT OTHERWISE THERE WERE NO SIGNIFICANT CHANGES ON EXAMINATION. ON (B)(6) 2011 THE PATIENT COMPLAINED OF PAIN ON THE SIDE OF BOTH LEGS; THAT THEY COULDN¿T LAY ON EITHER SIDE, AND PRESENTED AN ANTALGIC GAIT. THEY COMPLAINED THAT THEY STRUGGLE UP STAIRS AND MUST CARRY A CANE. THE DOCTOR¿S NOTES MENTION HYPERTROPHY OSSIFICATION AND LUMBAR SPONDYLOSIS. ON (B)(6) 2011 THE PATIENT PRESENTED LOW BACK PAIN AND SAID IT FELT ¿LIKE SHE HAD RIPPED HER MUSCLE FROM THE GROIN AREA.¿ THE PATIENT UNDERWENT A MRI OF THE RIGHT HIP WHICH DEMONSTRATED ¿SUBSTANTIAL ARTHRITIS IN THE RIGHT HIP WITH ARTICULAR CARTILAGE LOSS AND MARGINAL OSTEOPHYTE FORMATION; FLUID IN THE RIGHT HIP SLIGHTLY MORE THAN PHYSIOLOGICAL; FLUID ALONG THE COURSE OF THE PSOAS TENDON AND ALONG THE ILIACUS TENDIONMUSCULAR JUNCTION AND ILIACUS TENDON BUT THE INSERTION OF THE ILIOPSOAS TENDON ON THE LESSER TROCHANTER APPEARED INTACT. THE FINDING SUGGESTED SPRAIN OF THE ILIOPSOAS AS WELL AS POSSIBLE INJURY TO THE ILIACUS TENDINOMUSCULAR JUNCTION.¿ A DEXA SCAN WAS TAKEN WHICH SHOWED THAT THE LEFT HIP RESULTS WERE CONSISTENT WITH OSTEOPENIA. ON (B)(6) 2011 THE PATIENT PRESENTED WITH REOCCURRING PAIN WITH NEW SYMPTOMS OF CRAMPS ALONG THE ANTERIOR BUTTOCKS. ON (B)(6) 2012 THE PATIENT COMPLAINED OF PAIN AND DIFFICULTY SLEEPING. THE DOCTOR¿S NOTES MENTION FAILED BACK SYNDROME ON (B)(6) 2012 THE PATIENT PRESENTED WITH LOW BACK PAIN AND UNDERWENT A HELICAL CT OF THE LUMBAR SPINE WHICH SHOWED POST ANTERIOR AND POSTERIOR FUSION, WITH DISC CAGES FROM L2-3 TO L5-S1 LEVELS, LEFT L3-4 LAMINOTOMY, AND LEFT L2 TO L4 PEDICLE SCREWS. THERE WAS NO EVIDENCE FOR LOOSENING OR FRACTURE OF THE HARDWARE. THERE WAS MILD LEVOSCOLIOSIS, CENTERED AROUND L1-L2. NO LUMBAR CENTRAL SPINAL CANAL STENOSIS; L4-S AND L5-S1 MODERATE NEURAL FORAMEN STENOSIS, RELATED TO POSTERIOR BONE RIDGING (PROBABLY TOUCHING BOTH EXITING L4 AND LEFT L5 NERVE ROOTS)AND FACET HYPERTROPHY, PROBABLY TOUCHING BOTH EXITING L4 AND THE LEFT L5 NERVE ROOTS.¿ THE LUMBAR MUSCULATURE SHOWED ATROPHY AT MULTIPLE LEVELS. ON (B)(6) 2012 THE PATIENT COMPLAINED OF ¿PAIN LIKE SOMEONE TOOK A KNIFE STAB DOWN BOTH LEGS¿; NUMBNESS DOWN BOTH LAGS WHEN WALKING; LEFT SIDE PAIN TRAILING DOWN BACK; PAIN IN THE LEFT LEG IF LYING ON LEFT SIDE; AND NUMBNESS. THE DOCTOR NOTED MECHANICAL PAIN AND ¿HYDROPHILIC CELL FORMATION AROUND PEDICLE SCREWS¿. ON (B)(6) 2012 THE PATIENT PRESENTED WITH LOW BACK AND LEG PAIN AND UNDERWENT A MRI OF THE LUMBAR SPINE WHICH DEMONSTRATED ¿POST SPINAL FUSION, WITH DISC SPACES FROM L2-3 TO L5-S1, AND LEFT PEDICLE SCREWS FROM L2 TO L4; MODERATE LEFT L4-5 FORAMEN STENOSIS, RELATED TO POSTERIOR BONE RIDGING AND FACET HYPERTROPHY, PROBABLY, TOUCHING THELEFT L4 NERVE ROOTS. MILD FORAMEN STENOSIS ELSEWHERE, WITHOUT EVIDENT EFFECT ON THE NERVE ROOTS; OVERALL, THERE WERE NO SIGNIFICANT CHANGE SINCE THE (B)(6) 2012.¿ ON (B)(6) 2012 THE PATIENT PRESENTED WITH BACK, NECK, AND BILATERAL HAND NUMBNESS WITH PROGRESSIVE WEAKNESS IN BOTH HANDS. THE PATIENT REPORTED THAT SOMETHING ¿IS MOVING IN MY BACK¿. A SENSORY EXAM SHOWED DECREASED BILATERAL C4, C5, AND C6 TO PIN. ON (B)(6) 2012 THE PATIENT UNDERWENT A HELICAL CT SCAN WHICH DEMONSTRATED POST ANTERIOR AND POSTERIOR FUSION, WITH DISC CAGES FROM L2-3 TO L5-S1 LEVELS, LEFT L3-4 LAMINOTOMY, AND LEFT L2 TO L4 PEDICLE SCREWS. NO EVIDENCE FOR LOOSENING OR FRACTURE OF THE HARDWARE; MILD LEVOSCOLIOSIS, CENTERED AROUND L 1-2. NO LUMBAR CENTRAL SPINAL CANAL STENOSIS; L4-5 AND L5-S1 MODERATE NEURAL FORAMEN STENOSIS, RELATED TO POSTERIOR BONE RIDGING AND FACET OSTEOARTHRITIS; OVERALL THERE WAS NO SIGNIFICANT CHANGE SINCE THE (B)(6) 2012 MRI. A MRI OF THE CERVICAL SPINE WAS ALSO CONDUCTED AND THAT SHOWED POST ANTERIOR FUSION OF C5 TO C7, WITH METALLIC ARTIFACTS PARTIALLY OBSCURING THESE LEVELS; STRAIGHTENING OF THE CERVICAL SPINE; OVERALL, NO SIGNIFICANT CHANGE IN THE STENOSIS SINCE THE PRIOR EXAM IN (B)(6) 2012 AS FOLLOWS; C4-S: MODERATE THECAL SAC STENOSIS OF 8 MM AP, RELATED TO 3 MM POSTERIOR DISC BULGE ECCENTRIC TO RIGHT WITH SPUR AND CONGENITALLY SHORT PEDICLES. MARROW EDEMA AT THE INFERIOR PORTION OF THE C4 VERTEBRA. BILATERAL MODERATE NEURAL FORAMEN STENOSIS, RELATED TO UNCOVERTEBRAL AND FACET HYPERTROPHY, PROBABLY TOUCHING THE EXITING CS NERVE ROOTS; C3-4; BORDERLINE THECAL SANCTENSIS OF 9-10 MM AP, RELATED TO A 2-3 MM POSTERIOR DISC BULGE AND CONGENITALLY SHORT PEDICLES. MILD NEURAL FORAMEN STENOSIS, WITHOUT EVIDENT EFFECT ON THE NERVE ROOTS; AND NO CERVICAL CORD COMPRESSION OR DEFINITE CORD SIGNAL ABNORMALITY. ON (B)(6) 2012 THE PATIENT COMPLAINED OF LOW BACK PAIN, BILATERAL BUTTOCK PAIN WHICH RADIATED INTO THE HAMSTRINGS; RIGHT SHOULDER PAIN; INSOMNIA DUE TO PAIN (MAX SLEEP 15 MIN); TINGLING AND NUMBNESS BOTH HANDS; THE INABILITY TO STAND FOR MORE THAN 15 MIN; AND THE INABILITY TO PERFORM DAILY ACTIVITIES. A REVIEW OF A PREVIOUS CT OF THE NECK SHOWED ¿REASONABLE FUSION¿ THROUGH FUSION SITE; PARTIAL FUSION ANTERIORLY ON THE LEFT AT L4-L5. THE PATIENT PRESENTED OBESITY; PAIN; LEFT SHOULDER HIGHER THAN RIGHT AND RIGHT PELVIS HIGHER THAN LEFT; AND JOINT TENDERNESS WITH THE ASSESSMENT OF CERVICAL SPONDYLOSIS WITH MYELOPATHY AND RADICULOPATHY; NECK ADJACENT DISC DISEASE IN THE THESIS. ON (B)(6) 2012 THE PATIENT PRESENTED WITH SEVERE NUMBNESS AFFECTING THE THUMB, INDEX, AND MIDDLE FINGER AND NECK RADIATING DOWN BOTH UPPER EXTREMITIES WITH THE ASSESSMENT OF CERVICAL SPONDYLOSIS WITH MYELOPATHY A EMG OF BOTH EXTREMITIES WAS CONDUCTED WHICH DEMONSTRATED EVIDENCE OF MODERATE TO SEVERE DEGREE OF BILATERAL C5 TO C7 RADICULOPATHY; C6 AND C7 INNERVATED MUSCLES SHOWING AN ACUTE WITH CHRONIC DENERVATION. ¿THIS IS AN ABNORMAL STUDY¿. ON (B)(6) 2012 THE PATIENT PRESENTED WITH PAIN AND UNDERWENT A THORACOLUMBAR SPINE X-RAY (2 VIEW) WHICH DEMONSTRATED ROTARY SCOLIOSIS OF THE THORACOLUMBAR SPINE (L2-L3 WITH 11 DEGREES AND T10-T11 WITH 12 DEGREES) AND OSTEOPENIA. ON (B)(6) 2012 THE PATIENT PRESENTED WITH NECK, RIGHT SHOULDER, LOW BACK AND BILATERAL BUTTOCK AND LEG PAIN. THE PATIENT REPORTED HAVING FALLEN APPROXIMATELY ONE WEEK PRIOR AND COMPLAINED THAT SINCE THAT TIME THEIR SYMPTOMS WERE MUCH WORSE WITH THEIR RIGHT SHOULDER BEING IMMOBILE AND WITH MUCH PAIN. THE PATIENT ALSO COMPLAINED OF LOWER EXTREMITY NUMBNESS AND PAIN. IN THE DOCTOR¿S RX NOTES IT MENTIONED HYPERTROPHIC CALCIFICATION IN THE SUBCUTANEOUS AREA AT THE SIDE TO THE PEDICLE SCREW TRACT ¿WHEREBY AN INFUSE HAD CAUSED CALCIFICATION¿. PER THE DOCTOR¿S NOTES A MRI SHOWED COMPRESSION OF THE L4 NERVE ROOT. AND AN X-RAY SHOWED EARLY STAGES OF DISC DISEASE AT L1-L2 AND T12 ¿L1 AND CERVICAL SPONDYLOSIS WITH MYELOPATHY.
IT WAS REPORTED THAT ON (B)(6) 2009: THE PATIENT PRESENTED WITH DISCO-GENIC PAIN AT L2-L3, L3-L4. STATUS POST PREVIOUS FUSION AT L4-L5, L5-S1. THE PATIENT UNDERWENT SEGMENTAL INSTRUMENTATION, L2, L3, L4 BILATERALLY. POSTEROLATERAL INTER-TRANSVERSE PROCESS FUSION L2 TO L4 BILATERALLY WITH FORTROSS. ASPIRATION OF RIGHT ILIAC CREST FOR BONE MARROW. INTRA-OPERATIVE EMG TESTING OF PEDICLE SCREWS. FLUOROSCOPIC CONTROL. LOCAL ANESTHESIA. NO PATIENT COMPLICATIONS WERE REPORTED.
ON (B)(6) 2009 IT WAS REPORTED, PLIF PEEK L2-3, L3-4 W/ BMP-2AND ORTROSS; THE SPACER WAS THEN TAKEN AND FILLED WITH BMP AND THEN INSERTED UNDER IMAGE CONTROL. ON (B)(6) 2011 REVISION, DORSAL LUMBAR FUSION,LAMINAE L3-4, L4-5 USING PATIENT'S BON AND 2.8 CUBIC CM BMP; BMP APPROX 1.4 W/ PATIENT'S CORTICAL CANCELLOUS BONE W/ ACTIFUSE ON TOP. CHRONIC PAIN AND NERVE DAMAGE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280479 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | M110807AAI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |