INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2014-04165
- Event Type
- Injury
- Date Received
- October 29, 2014
- Report Date
- September 29, 2014
- 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
(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.
IT WAS REPORTED THAT ON (B)(6) 2005: THE PATIENT PRESENTED WITH CHRONIC NECK PAIN WITH RADICULOPATHY TO ARMS BILATERALLY. THE PATIENT UNDERWENT A CERVICAL SPINE MRI WITHOUT CONTRAST. CONCLUSION: LARGE EXTRUDED CENTRAL C5-6 DISC HERNIATION. ON (B)(6) 2005: THE PATIENT PRESENTED WITH LOW BACK PAIN. THE PATIENT UNDERWENT MRI OF THE LUMBAR SPINE WITHOUT CONTRAST. IMPRESSION: MILD DEGENERATIVE DISC CHANGES L4-5; NO EXTRUDED DISC HERNIATION OR SPINAL CANAL STENOSIS. ON (B)(6) 2005: THE PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSES OF CERVICAL DISC DISEASE WITH TIGHT STENOSIS AND CORD COMPRESSION, C5-6. DURING THE PROCEDURE, IT WAS FOUND THE PATIENT ALSO HAD PSEUDOARTHROSIS AT C6-7. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: TWO LEVEL CERVICAL DISCECTOMY AND INTERPOSITION OF BONE GRAFT WITH THE OPERATIVE MICROSCOPE; SPINAL CORD AND DURAL DECOMPRESSION AT C5-6 AND REPEAT FUSION C6-7. ON (B)(6) 2005: THE PATIENT UNDERWENT MRI OF THE LUMBAR SPINE. FINDINGS: SOME DEHYDRATION AND VERY SLIGHT NARROWING. ON (B)(6) 2005: THE PATIENT PRESENTED WITH LUMBAR SPONDYLOSIS AND HISTORY OF BACK SURGERY. THE PATIENT UNDERWENT A DIAGNOSTIC LUMBAR DISKOGRAM. ON (B)(6) 2005: THE PATIENT PRESENTED WITH LOW BACK PAIN. ON (B)(6) 2005: THE PATIENT PRESENTED WITH LOW BACK PAIN WITH RADIATION INTO THE LEGS. ON (B)(6) 2005: THE PATIENT UNDERWENT A DISCOGRAM THAT SHOWED SOME CONCORDANCE OF PAIN FROM BOTH L4-5 AND L5-S1. PATIENT UNDERWENT AN ANESTHETIC DISCOGRAM AT L4-5 WHICH RELIEVE 90% (B)(6) 2006 : THE PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSES OF DISC DEGENERATION, DISC HERNIATION, LUMBAR SPONDYLOSIS, LATERAL RECESS STENOSIS, AND EPIDURAL SCAR TISSUE FORMATION. THE PATIENT UNDERWENT A L4-5 ANTERIOR LUMBAR INTERBODY FUSION AND PLACEMENT OF LT INTERBODY FUSION CAGES WITH RHBMP-2/ACS. PER THE OP NOTES, AFTER APPROPRIATE SIZED LT CAGES WERE SELECTED, THEY WERE FILLED WITH RHBMP-2/ACS. NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2006: THE PATIENT PRESENTED WITH BACK PAIN, LEFT SIDED LEG PAIN, AND LEFT FOOT DROP. THE PATIENT UNDERWENT CT OF THE LUMBAR SPINE WITHOUT CONTRAST. IMPRESSION: THERE ARE A FEW SURGICAL CLIPS IN THE LEFT PARASPINOUS SOFT TISSUES. THERE IS MILD INCREASED DENSITY AT THE L4-5 END PLATES, MOST LIKELY REPRESENTING EDEMA OR SCLEROSIS. ON (B)(6) 2006: THE PATIENT UNDERWENT MRI OF THE LUMBAR SPINE WITH AND WITHOUT CONTRAST DUE TO LOW BACK PAIN, LEFT LEG PAIN, AND A PREVIOUS SURGERY. IMPRESSION: L4-5 POSTERIOR LAMINECTOMY WITH DISCECTOMY WITH ENHANCING GRANULATION TISSUE POSTERIOR, POSTERIOR LATERAL AND ANTERIOR LATERAL TO THE RIGHT OF THE SPINAL CANAL, ALONG WITH POSTERIOR LATERAL OSTEOPHYTIC HYPERTROPHY RESULTING IN MILD ENCROACHMENT IN THE LATERAL RECESSES. THE AP DIAMETER OF THE SPINAL CANAL IS 10-11 MM. ON (B)(6) 2006 : THE PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSES OF HERNIATED NUCLEUS PULPOSUS, L4-5 LEFT AND STATUS POST ANTERIOR BACK CAGE FUSION L4-5. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: CONTINUOUS INTRAOPERATIVE EMG MONITORING FOR ONE HOUR; CONTINUOUS INTRAOPERATIVE EMG MONITORING OF 10 NERVE ROOTS (L2, L3, L4, L5, S1 BILATERALLY FOR ONE HOUR); USE OF INTRAOPERATIVE FLUOROSCOPY; L4 LAMINECTOMY; LUMBAR DISCECTOMY L4-5 LEFT; TRANSVERSE PROCESS ARTHRODESIS, L4-5; PREPARATION OF AUTOGRAFT ON THE SIDE TABLE; STRYKER PEDICLE SCREW FIXATION L4-5. ON (B)(6) 2006: THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2006: THE PATIENT UNDERWENT MRI OF THE LUMBAR SPINE WITH AND WITHOUT CONTRAST. IMPRESSION: THERE IS INDENTATION OF THE VENTRAL ASPECT OF THE THECAL SAC WHICH IS PROBABLY AT LEAST IN PART ARTIFACTUAL IN NATURE. MILD ANNULAR BULGE IS ALSO PROBABLY PRESENT. THERE IS NORMAL ALIGNMENT. DORSAL FLUID COLLECTION AT L4-5 MOST CONSISTENT WITH A POSTOPERATIVE SEROMA. THIS PRODUCES MILD DEFORMITY OF THE DORSAL ASPECT OF THE THECAL SAC. ON (B)(6) 2006: THE PATIENT UNDERWENT MRI OF THE CERVICAL SPINE WITH AND WITHOUT CONTRAST. IMPRESSION: LARGE CENTRAL EXTRADURAL DEFECT IS SEEN AT C4-5. THE APPEARANCE IS CONSISTENT WITH A LARGE CENTRAL DISC PROTRUSION. THERE IS DEFORMITY OF THE CORD AND NARROWING OF THE SPINAL CANAL. MARGINAL SPURRING IS NOTED AT BOTH LEVELS WITHOUT SPINAL STENOSIS OR DEFORMITY OF THE CORD. THERE IS MILD NARROWING OF THE NEUROFORAMINA BILATERALLY AT BOTH LEVELS. ON (B)(6) 2007: THE PATIENT UNDERWENT MRI OF THE CERVICAL SPINE. FINDINGS: SEVERE CERVICAL SPINAL CANAL STENOSIS AT C4-5 WHICH IS THE LEVEL ABOVE HER PREVIOUS FUSION. ON (B)(6) 2007: THE PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSES OF RETAINED HARDWARE AT C5-7 AND HERNIATED NUCLEUS PULPOSUS AT C4-5. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR CERVICAL DISCECTOMY AT C4-5; ANTERIOR CERVICAL PLATING REMOVAL AT C5,6,7; USE OF MICROSCOPE; ANTERIOR CERVICAL ARTHRODESIS AT C4-5; PLACEMENT OF ANTERIOR CERVICAL INTERBODY DEVICE/ PEEK SPACER AT C4-5; PREPARATION OF ALLOGRAFT; STRYKER LOCKING PLATE AT C4-5. THE PATIENT UNDERWENT INTRAOPERATIVE X-RAYS OF THE CERVICAL SPINE. ON (B)(6) 2007: THE PATIENT UNDERWENT CT OF THE CERVICAL SPINE WITHOUT CONTRAST. IMPRESSION: POST-SURGICAL CHANGES; DEGENERATIVE DISC DISEASE WITH ENDPLATE IRREGULARITY AT C5-6 AND C6-7. CT OF THE BRAIN WAS NEGATIVE. X-RAY OF THE SHOULDER WAS NEGATIVE. THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2007: THE PATIENT UNDERWENT CT OF THE LUMBAR SPINE. FINDINGS: POSTOPERATIVE CHANGES FROM HER PEDICLE FIXATION L4-5. CT OF THE CERVICAL SPINE SHOWS POSTOPERATIVE CHANGES AND DISCECTOMY AT C4-5. HE PATIENT REPORTS HAVING A FALL SHORTLY AFTER HER LAST SURGERY. THIS PRODUCED BACK AND LEG PAIN AND SOME RIGHT SIDED ARM PAIN. ON (B)(6) 2007: THE PATIENT UNDERWENT MRI OF THE CERVICAL SPINE WITH AND WITHOUT CONTRAST. IMPRESSION: LEFT PARACENTRAL TO FORAMINAL DISC PROTRUSION AT C2-3 IN COMBINATION WITH OSTEOPHYTIC RIDGING THAT CAUSES COMPROMISE OF THE LEFT FORAMEN; MODERATE FORAMINAL NARROWING BILATERALLY AT C5-6. ON (B)(6) 2007: THE PATIENT UNDERWENT MRI OF THE LUMBAR SPINE WITH AND WITHOUT CONTRAST. IMPRESSION: LAMINECTOMY L4 AND L5 WITH BILATERAL PEDICLE SCREWS AND POSTERIOR FUSION RODS AS WELL AS INTERVENING DISC SPACERS. MILD, DIFFUSE ENHANCEMENT L4 AND L5 VERTEBRAL BODIES PROBABLY POST-SURGICAL. ON (B)(6) 2008: THE PATIENT PRESENTED WITH SEVERE BACK PAIN AND HAD SOME ARM AND NECK PAIN AS WELL AND HER PAIN TODAY SOUNDS MORE CARPAL TUNNEL IN NATURE BILATERALLY. ON (B)(6) 2008: THE PATIENT UNDERWENT EMG OF THE UPPER EXTREMITIES WHICH WAS CAME BACK NORMAL. ON (B)(6) 2009: THE PATIENT UNDERWENT MRI OF THE CERVICAL SPINE. FINDINGS: POSTOPERATIVE CHANGES C4-5; BROAD BASED DISK BULGE AT C3-4; AT C5-6 THERE IS MILD ARTHRITIS WITH SOME MILD LEFT SIDED NEUROFORAMINAL ENCROACHMENT. ON (B)(6) 2009: THE PATIENT PRESENTED WITH CERVICAL RADICULAR PAIN. THE PATIENT UNDERWENT A CERVICAL EPIDUROGRAM AND A CERVICAL EPIDURAL STEROID INJECTION AT C4-5. NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2009: THE PATIENT PRESENTED WITH LOW BACK PAIN AND FOOT DROP. ON (B)(6) 2009: THE PATIENT UNDERWENT EMG AND CERVICAL DISCOGRAM C3-4 AND C2-3. NO COMPLICATIONS WERE NOTED. NORMAL STUDY. ON (B)(6) 2009: THE PATIENT UNDERWENT X-RAYS OF THE LUMBAR SPINE. IMPRESSION: SURGICAL CHANGES OF THE LUMBAR SPINE. ALIGNMENT AND HARDWARE IS INTACT. THERE IS MILD CURVATURE OF THE SPINE TO THE RIGHT. (B)(6) 2009: THE PATIENT PRESENTED WITH NECK AND LOWER BACK PAIN THAT IS GRADUALLY GETTING WORSE. THE PATIENT REPORTS PAIN RADIATING TO UPPER AND LOWER EXTREMITIES. THE PATIENT UNDERWENT X-RAYS OF THE CERVICAL SPINE. FINDINGS: MATURE FUSION AT C4-5. APPEARS TO BE A NON-UNION AT C5-6 AND C6-7. THERE ARE BROKEN SCREWS STATUS POST PLATE REMOVAL AT THE C6-7 LEVEL. THE SCREWS ARE WITHIN THE C7 VERTEBRAL BODY. SHE HAS MOVEMENT ACROSS THE JOINTS POSTERIORLY AT C5-6 AND C6-7. THERE IS NO ABNORMAL MOVEMENT AT C3-4 AND C7-T1. THE PATIENT ALSO UNDERWENT X-RAYS OF THE LUMBAR SPINE. FINDINGS: RETAINED INSTRUMENTATION IN PLACE AT L4-5 WITH RAY CAGES IN PLACE AT L4-5 ANTERIORLY. SHE HAS DEVELOPED A LUMBAR DEGENERATIVE SCOLIOSIS AFFECTING THE L3-4 AND L5-S1 SEGMENTS. THERE IS ROTATION THROUGH THE LUMBER SPINE. ON (B)(6) 2009: THE PATIENT UNDERWENT CT/MYELOGRAM DUE TO PSEUDOARTHROSIS. FINDINGS: NON-UNION AT C5-6 AND C6-7 WITH RETAINED SCREWS IN THE C7 VERTEBRAL BODY. THERE IS MINIMAL ANTERIOR BULGE SEEN AT THE LEVEL C6-7. ON (B)(6) 2010: THE PATIENT PRESENTED WITH A CT/MYELOGRAM OF THE CERVICAL SPINE. FINDINGS: NON-UNION AT C5-6 AND C6-7 WITH RETAINED SCREWS IN THE C7 VERTEBRAL BODY. APPARENT FUSION AND INSTRUMENTATION AT C4-5. NO EVIDENCE OF CERVICAL STENOSIS, CENTRAL OR FORAMINAL. ON (B)(6) 2010: CT SCAN OF THE LUMBAR SPINE REVEALS A SOLID INTERBODY FUSION AT L4-5 WITH NO INSTRUMENTATION LOOSENING OR FAILURE. THERE IS DEGENERATIVE DISC DISEASE AT L3-4 WITH BROAD DISC BULGING AND HYPERTROPHY OF POSTERIOR ELEMENTS RESULTING IN A MODERATE SPINAL STENOSIS WITH FORAMINAL COMPROMISE. ON (B)(6) 2010: THE PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSES OF POSTLAMINECTOMY SYNDROME. THE PATIENT UNDERWENT A TRIAL SPINAL CORD STIMULATOR IMPLANTATION WITH 8 LEADS. ON (B)(6) 2010: MRI OF THE LUMBAR SPINE SHOWS SOME DEGENERATIVE CHANGES ABOVE AND BELOW HER FUSION. ON (B)(6) 2010: THE PATIENT PRESENTED AFTER HAVING HAD A FAILED SPINAL CORD STIMULATOR TRIAL. THE PATIENT REPORTS CONTINUED PAIN IN HER BACK AND LEFT THIGH. SHE ALSO REPORTS NECK PAIN AND BILATERAL UPPER EXTREMITY PAIN. ON (B)(6) 2010: THE PATIENT UNDERWENT EMG-NERVE CONDUCTION STUDY. FINDINGS: CHRONIC C5 RADICULOPATHY ON THE LEFT SIDE. MRI ALSO REVEALED C3-4 DISC BULGE WITH NARROWING OF HER SPINAL CANAL WHICH IS MILD AT THIS LEVEL. ON (B)(6) 2010: THE PATIENT PRESENTED WITH NECK AND LOWER BACK PAIN. THESE PAINS HAVE GRADUALLY BECOME WORSE. IMPRESSION: NON-UNION AT C5-6 AND C6-7 AND WHAT APPEARS TO BE A SOLID FUSION AT C4-5. ON (B)(6) 2010 : THE PATIENT PRESENTED WITH THE FOLLOWING PREOPERATIVE DIAGNOSES: PSEUDOARTHROSIS C5-6 AND C6-7 STATUS POST ANTERIOR CERVICAL DISCECTOMY AND ATTEMPTED FUSION; STATUS POST C4-5 ACDF WITH SOLID FUSION; ADJACENT LEVEL DEGENERATIVE CHANGES WITH CENTRAL DISC BULGE AND STENOSIS C3-4; DEGENERATIVE FACET JOINT CHANGES C7-T1; NECK PAIN; BILATERAL UPPER EXTREMITY PAIN AND CHRONIC RADICULOPATHY. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: PLACEMENT OF VERTEX MAX LATERAL MASS INSTRUMENTATION C3,C4,C5, AND C6; PLACEMENT OF MEDTRONIC LEGACY TRANSPEDICULAR INSTRUMENTATION T1 AND T2; POSTEROLATERAL FUSION C3-T2 USING RHBMP-2/ACS AND 60CC OF CRUSHED CANCELLOUS BONE; USE OF SSEP AND EMG MONITORING. PER THE OP NOTES, FOLLOWING DECORTICATION OF THE POSTERIOR SPINAL ELEMENTS, ONE LARGE KIT OF RHBMP-2/ACS WAS ROLLED AROUND CRUSHED ALLOGRAFT AND PLACED IN THE DECORTICATED FACET JOINTS FROM C3-T2. ON TOP OF THAT, THE REMAINING 60CC OF CRUSHED BONE WAS PLACED OVER THE POSTERIOR SPINAL ELEMENTS FROM C3-T2. NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2010: THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2011: THE PATIENT¿S X-RAYS OF THE LATERAL SPINE WERE REVIEWED. FINDINGS: TRANSPEDICULAR INSTRUMENTATION IN PLACE AT L4-5 WITH NO INSTRUMENTATION OR LOOSENING OR FAILURE. SHE DOES HAVE DEGENERATIVE CHANGES AT L3-4 WITH A RETROLISTHESIS OF L3 ON L4. SHE ALSO HAS MILD LUMBAR SCOLIOSIS WITH CONVEXITY TO THE RIGHT. ON (B)(6) 2011: THE PATIENT UNDERWENT MRI OF THE LUMBAR SPINE WITHOUT CONTRAST DUE TO BACK AND BILATERAL LEG PAIN. IMPRESSION: POST-OPERATIVE CHANGES OF THE LUMBAR SPINE CONSISTENT WITH L4-5 FUSION; DEGENERATIVE CHANGES OF THE LUMBAR SPINE; THERE APPEARS TO BE SIGNIFICANT RIGHT NEURAL FORAMINAL STENOSIS AT L3-4 ON THE BASIS OF DISC BULGE. ON (B)(6) 2011: THE PATIENT PRESENTED WITH LOW BACK PAIN WHICH RADIATES TO HER LEFT LOWER EXTREMITY AS WELL AS NECK PAIN WHICH RADIATES TO HER LEFT UPPER EXTREMITY. ASSESSMENT: CHRONIC PAIN SYNDROME; FAILED BACK SYNDROME; LUMBAR DISC DISEASE; SCIATICA; FAILED SURGICAL NECK SYNDROME; CERVICAL DISC DISEASE; UPPER EXTREMITY RADICULAR PAIN; POSSIBLE OBSTRUCTIVE SLEEP APNEA; INSOMNIA; ANXIETY; CHRONIC PANCREATITIS. ON (B)(6) 2011: THE PATIENT PRESENTED WITH CONTINUED BACK AND LEG PAIN. ON (B)(6) 2011: THE PATIENT PRESENTED WITH THE FOLLOWING PREOPERATIVE DIAGNOSES: RETAINED L4-5 TRANS-PEDICULAR INSTRUMENTATION STATUS POST PRIOR L4-5 FUSION; LOW BACK PAIN; LEG PAIN. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: REMOVAL OF PREVIOUSLY PLACED L4-5 TRANSPEDICULAR INSTRUMENTATION; EXPLORATION OF FUSION L4-5. NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2011: THE PATIENT PRESENTED FOR A US DUPLEX ARTERIAL OF THE LEFT ARM. IMPRESSION: UNREMARKABLE ARTERIAL FLOW TO THE LEFT UPPER EXTREMITY. THE PATIENT UNDERWENT US DOPPLER VENOUS OF THE LEFT ARM. IMPRESSION: NO EVIDENCE FOR VENOUS THROMBUS IN THE LEFT UPPER EXTREMITY. ON (B)(6) 2011: THE PATIENT UNDERWENT CT OF THE THORACIC SPINE WITHOUT CONTRAST DUE TO BACK PAIN. IMPRESSION: NORMAL VERTEBRAL BODY HEIGHTS; POSTERIOR FUSION T1 AND T2. DISC HEIGHTS PRESERVED. NO BONY FORAMINAL OR SPINAL CANAL STENOSIS; MILD DEXTROSCOLIOSIS MID-THORACIC SPINE. THE PATIENT ALSO UNDERWENT CT OF THE CERVICAL SPINE WITHOUT CONTRAST DUE TO NECK PAIN. IMPRESSION: POSTERIOR FUSION C3-T2. ANTERIOR FUSION C4 AND C5 WITH INCORPORATION OF INTERVENING DISC SPACER. OSSEOUS FUSION OF C5 THROUGH C7. TWO SCREW FRAGMENTS WITHIN C7 VERTEBRA. NO BONY SPINAL CANAL OR FORAMINAL STENOSIS. PARASPINAL SOFT TISSUES UNREMARKABLE. ON (B)(6) 2011: THE PATIENT PRESENTED WITH LEFT UPPER EXTREMITY SWELLING AND SOME DIFFICULTY WITH NECK PAIN AS WELL AS ONGOING OCCIPITAL PAIN AND HEADACHE. THE PATIENT UNDERWENT US DOPPLER VENOUS OF THE LEFT ARM. IMPRESSION: NO ULTRA-SONOGRAPHIC EVIDENCE FOR DEEP VEIN THROMBOSIS IN THE VISUALIZED DEEP VENOUS STRUCTURES OF THE LEFT UPPER EXTREMITY. ON (B)(6) 2011: THE PATIENT PRESENTED WITH INCREASED LOWER EXTREMITY RADICULAR PAIN PARTICULARLY IN HER FEET. ON (B)(6) 2011: THE PATIENT UNDERWENT CT OF THE LUMBAR SPINE WITHOUT CONTRAST DUE TO LOWER BACK PAIN AND RADICULOPATHY. IMPRESSION: MINIMAL DEGENERATIVE ENDPLATE AND DEGENERATIVE FACET CHANGES; L4-5 FUSION APPEARS TO BE IN GOOD ANATOMIC ALIGNMENT; STRANDING IN THE PARASPINOUS SOFT TISSUES AT THE L4-5 LEVEL IS LIKELY POST-OPERATIVE. THE PATIENT UNDERWENT MRI OF THE LUMBAR SPINE WITH AND WITHOUT CONTRAST DUE TO LOWER BACK PAIN AND RADICULOPATHY. IMPRESSION: MODERATE TO SEVERE RIGHT NEURAL FORAMINAL STENOSIS IS PRESENT AT THE L3-4 LEVEL; INCREASING CONTRAST ENHANCEMENT IS PRESENT IN THE L4-5 VERTEBRAL BODIES AS WELL IN THE POSTERIOR PARASPINAL SOFT TISSUES. THIS MAY BE POSTOPERATIVE EDEMA. ON (B)(6) 2011: THE PATIENT PRESENTED WITH CT AND MRI SCAN OF THE LUMBAR SPINE. FINDINGS: HER FUSION AT L4-5 WHERE THE INSTRUMENTATION WAS REMOVED APPEARS TO BE INTACT. SHE HAS A RIGHT L3-4 DISC BULGE WHICH DOES CONTRIBUTE TO RIGHT L3-4 FORAMINAL STENOSIS AND COMPRESSION OF HER RIGHT L3 NERVE ROOT. ON (B)(6) 2012: THE PATIENT PRESENTED WITH ONGOING PAIN IN HER LEFT LEG AND FOOT AND RIGHT THIGH AND BACK. ON (B)(6) 2012: THE PATIENT PRESENTED WITH NECK, BACK AND LEG PAIN THAT SHE CLAIMS IS GRADUALLY GETTING WORSE. THE PATIENT UNDERWENT X-RAYS OF THE SPINE DUE TO SCOLIOSIS. THERE IS CURVATURE OF THE LOWER THORACIC SPINE, CONVEXITY TO THE LEFT OF ABOUT 16 DEGREES MEASURED FROM T7-T12 WITH THE APEX AT T10. ON (B)(6) 2012: THE PATIENT UNDERWENT AN MRI OF THE LUMBAR SPINE WITHOUT CONTRAST. IMPRESSION: DISC BULGING AT L3,L4, NO EVIDENCE OF HERNIATION; SOLID FUSION AT L4-5, AND BILATERAL LAMINECTOMIES AT L4; NO ACUTE ABNORMALITIES ARE SEEN, NO EVIDENCE OF DISC HERNIATION. ON (B)(6) 2012: THE PATIENT PRESENTED WITH LOWER BACK AND LEG PAIN. ON (B)(6) 2012: THE PATIENT UNDERWENT MRI OF THE CERVICAL SPINE DUE TO LEFT ARM WEAKNESS AND NECK PAIN. IMPRESSION: INTERVAL POSTERIOR FUSION T1 AND T2 COMPARED TO MRI IN (B)(6) 2007; ANTERIOR FUSION C4 AND C5; OSSEOUS FUSION C6 AND C7 MAY BE CONGENITAL OR POST-SURGICAL. ON (B)(6): THE PATIENT UNDERWENT MRI OF THE LUMBAR SPINE. FINDINGS: RIGHT L3-4 PARASAGITTAL AND FORAMINAL DISC HERNIATION WITH RESULTANT RIGHT L3-4 FORAMINAL STENOSIS. ON (B)(6) 2013: THE PATIENT PRESENTED WITH BACK AND RIGHT LEG AND THIGH PAIN AND ALSO SOME NECK AND LEFT UPPER EXTREMITY PAIN. ASSESSMENT: RIGHT L3-4 PARASAGITTAL AND FORAMINAL DISC HERNIATION WITH ONGOING AND RESULTANT RIGHT BACK AND THIGH PAIN. ON (B)(6) 2013 : THE PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSES OF RIGHT L3-4 PARASAGITTAL DISC HERNIATION WITH RIGHT L3 RADICULOPATHY AND LOW BACK PAIN. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: RIGHT L3-4 FACETECTOMY AND HEMILAMINECTOMY FOR DECOMPRESSIVE PURPOSES; PLACEMENT OF MEDTRONIC LEGACY TRANSPEDICULAR INSTRUMENTATION NON-SEGMENTAL L3-4; TRANSFORAMINAL LUMBAR INTERBODY FUSION USING ILIAC CREST BONE GRAFT; PLACEMENT OF MEDTRONIC CAPSTONE PEEK INTERBODY DEVICE L3-4; POSTEROLATERAL FUSION L3-4 USING LOCAL BONE AUTOGRAFT AND ILIAC CREST BONE GRAFT; HARVEST OF RIGHT ILIAC CREST BONE GRAFT THROUGH SEPARATE INCISION NON-STRUCTURAL; HARVEST OF BONE AUTOGRAFT THROUGH THE SAME MIDLINE INCISION NON-STRUCTURAL; USE OF SSEP AND EMG "MONITROGIN". NO PATIENT COMPLICATIONS NOTED. ON (B)(6) 2013: THE PATIENT WAS DISCHARGED HOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 691678 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |