INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2014-03393
- Event Type
- Injury
- Date Received
- August 5, 2014
- Report Date
- August 3, 2015
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
(B)(4).
(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.
ON (B)(6) 2011: PATIENT PRESENTED WITH PAIN IN HER RIGHT LOWER EXTREMITY. PATIENT TRIED MULTIPLE CONSERVATIVE TREATMENTS WITHOUT RELIEF. PRE-OP DIAGNOSIS: PSEUDOARTHROSIS AT L3-L4. PATIENT UNDERWENT ANTERIOR LUMBAR INTERBODY FUSION THROUGH A TRANSPSOAS APPROACH WITH ANTERIOR INTERNAL FIXATION AND INSERTION OF PEEK CAGE. PER OP NOTE, NEUROMUSCULAR TESTING WAS CARRIED OUT THROUGHOUT THIS PROCEDURE. FLUOROSCOPY WAS USED FOR GUIDANCE. DURING THE SURGERY, RH-BMP2/ACS, GRAFT AND SCREWS. THERE WERE NO COMPLICATIONS. ON (B)(6) 2011: PATIENT WAS DISCHARGED WITH LUMBAR SPINAL STENOSIS WITHOUT CLAUDICATION AS PRINCIPAL DIAGNOSIS AND FOLLOWING SECONDARY DIAGNOSES: IDIOPATHIC SCOLIOSIS; LUMBOSACRAL DISK DEGENERATION; STATUS POST ARTHRODESIS; HYPERTENSION; OSTEOARTHROSIS; DEPRESSION; HYPERLIPIDEMIA; ANXIETY; ESOPHAGEAL REFLUX. ON (B)(6) 2011: PATIENT UNDERWENT CT OF LUMBAR SPINE WITHOUT CONTRAST. IMPRESSION: THE EXAMINATION SHOWS A MILD SCOLIOTIC CURVE OF THE MID TO UPPER LUMBAR SPINE CONVEX TO THE LEFT WITHOUT COMPRESSION FRACTURE; THERE HAS BEEN DISCECTOMY WITH INTERBODY FUSION HARDWARE PLACEMENT AT L3-4, L4-5 AND L5-S1 AS DESCRIBED EARLIER. THERE IS ADEQUATE DECOMPRESSION OF THE L4-5 AND L5-S1 DISC SPACES; THERE IS LATERAL FUSION HARDWARE ALSO SEEN AT THE L3-4 LEVEL ON THE LEFT. THE POSTERIOR FUSION HARDWARE APPEARS INTACT. PATIENT ALSO UNDERWENT CT OF THE PELVIS INCLUDING THE SI JOINTS DUE TO SCOLIOSIS. IMPRESSION: POSTOPERATIVE CHANGES ARE SEEN IN THE LOWER LUMBAR SPINE AND SACRUM CONSISTENT WITH POSTERIOR FUSION HARDWARE PRESENT; THERE IS SCLEROTIC CHANGE ABOUT THE SI JOINTS; NO BONE DESTRUCTION, FRACTURE, OR FEMORAL HEAD AVN IS APPRECIATED. ON (B)(6) 2012: PATIENT UNDERWENT MRI C SPINE WITHOUT CONTRAST DUE TO NECK PAIN. IMPRESSION: C4-5 DISC BULGE AND MILD RIGHT NEURAL FORAMINAL STENOSIS SECONDARY TO UNCINATE SPUR; MODERATE LEFT C5-6 NEURAL FORAMINAL STENOSIS AND UNCINATE SPUR. ON (B)(6) 2013: PATIENT UNDERWENT LEFT HIP X-RAY DUE TO LEFT HIP PAIN. IMPRESSION: THERE ARE MILD ARTHRITIC CHANGES ABOUT THE GREATER TROCHANTER OF THE FEMUR AND THE ACETABULUM; POSTOPERATIVE CHANGES TO THE DISTAL SPINE; MILD DEGENERATIVE CHANGES TO THE LEFT SACROILIAC JOINT. ON (B)(6) 2013: PATIENT UNDERWENT MRI LUMBAR SPINE DUE TO LOW BACK PAIN. IMPRESSION: THERE IS A MILD BULGING ANNULUS OF L4/L3 WITH MILD TRANSVERSE SPINAL STENOSIS ON THE RIGHT; STATUS POST PEDICLE SCREWS AND POSTERIOR RODS OF L4/L5 AND L5/S1 WHICH IS IN SATISFACTORY ALIGNMENT AND POSITION. THERE IS A STATUS POST WIDE LAMINECTOMY; DISC SPACE SPACER OF L4/L3 WITH NO EVIDENCE OF DISPLACEMENT; POST SURGICAL CHANGES SEEN IN THE POSTERIOR ELEMENTS OF THE LUMBAR SPINE; STRAIGHTENING OF THE NORMAL LORDOTIC CURVE COMPATIBLE POST SURGICAL CHANGES; DEGENERATIVE DISC DISEASE AND JOINT DISEASE; HIGH DENSITY SEEN WITHIN THE S1/L5 DISC SPACE MAY BE COMPATIBLE WITH A DISC SPACE SPACER OR POST SURGICAL CHANGES. CLINICAL CORRELATION IS ADVISED; NO ACUTE OSSEOUS ABNORMALITY.
IT WAS REPORTED THAT ON (B)(6) 2006, THE PATIENT PRESENTED WITH LOW BACK PAIN AND UNDERWENT A LUMBAR SPINE MYELOGRAM WHICH DEMONSTRATED MILD LEVOSCOLIOSIS WITH EVIDENCE OF PRIOR SURGERY AND POSTEROLATERAL FUSION WITH A ROD WITH LAMINAR HOOKS ON THE RIGHT SIDE; MASS EFFECT ON THE THECAL SAC AT THE L4-5 AND L5-S1 LEVELS WITH SOME MILD TO MODERATE CANAL STENOSIS NOTED AT L4-5, WITH VENTRAL, POSTERIOR, AN ANTEROLATERAL INDENTATION SEEN ON THE THECAL SAC. THERE WAS MASS EFFECT NOTED ON THE EXITING L5 NERVE ROOT; AND L5-DS1 WITH VENTRAL AND PROMINENT LEFT ANTEROLATERAL INDENTATION SEEN ON THE THECAL SAC. THERE WAS LEFT SIDED INDENTATION APPEARING TO BE RELATED TO THE HYPERTROPHIC FACET. AND THERE WAS SOME MASS EFFECT ON THE LEFT S1 NERVE ROOT AS NOTED IN THE THECAL SAC. THE PATIENT ALSO UNDERWENT A LUMBAR SPINE CT WHICH SHOWED LEVOSCOLIOSIS WITH POSTERIOR FUSION AND RIGHT SIDED ROD WITH LAMINAR HOOK FROM T11 THROUGH L4. THE MOST SUPERIOR LAMINAR HOOKS DID NOT APPEAR TO BE COVERED WITH FUSION MATERIAL; L5-S1 DEMONSTRATE DIFFUSE DISC BULGE WITH SOME FACET HYPERTROPHIC CHANGES; THERE WERE SOME SOFT TISSUE MATERIAL NOTED IN THE LEFT VENTRAL EPIDURAL SPACE WHICH WAS SUSPECTED AS A PROTRUSION WITH SOME MASS EFFECTS ON THE THECAL SAC ¿ THIS CORRESPONDED WITH THE MYELOGRAPHIC ABNORMALITIES. L4-5 WITH MILD TO MODERATE CIRCUMFERENTIAL CANAL STENOSIS. VASCULAR CALCIFICATIONS. THERE WAS ALSO A SUSPECT RIGHT S2 PERINEURAL CYST MEASURING 2.0 X 1.0 CM WHICH APPEARED TO HAVE WIDENED THE RIGHT NEURAL FORAMEN. ON (B)(6) 2006, THE PATIENT PRESENTED WITH SCOLIOSIS AND MILD DEGENERATIVE DISC AND FACET DISEASE WITH POSSIBLE CANAL STENOSIS. THERE WAS A POSTERIOR ROD IN PLACE FROM APPROXIMATELY T11 TO L4. ON (B)(6) 2007, THE PATIENT UNDERWENT A CT OF THE THORACIC SPINE WHICH DEMONSTRATED HARRINGTON ROD PLACEMENT EXTENDING ON THE RIGHT FROM T11 THROUGH L4; NO EVIDENCE OF COMPRESSION FRACTURE OF SPONDYLOLISTHESIS OF THE THORACIC VERTEBRAE; AND DEGENERATIVE ENDPLATE SCLEROTIC CHANGES AND OSTEOPHYTES IN THE MID TO LOWER T-SPINE. THERE WAS NO FOCAL DISC HERNIATION OR STENOSIS WITHIN THE THORACIC SPINE. ON (B)(6) 2007, THE PATIENT PRESENTED WITH WORSENING LOWER BACK PAIN AND LEFT LEG PAIN AND THE PREOPERATIVE DIAGNOSIS OF SEVERE ADULT DEGENERATIVE DISC DISEASE AT L4-L5 AND L5-S1. THE PATIENT UNDERWENT SURGERY WHICH CONSISTED OF SPINAL OSTEOTOMIES AT L4-5 AND L5-S1; EXPLORATION OF FUSION AND REMOVAL OF RETAINED OF INTERNAL FIXATION DEVICE; INSERTION OF PEEK CAGES AT L4-5 AND L5-S1; AND POSTERIOR SPINAL FUSION WITH INSTRUMENTATION L4 TO THE SACRUM. PER THE OPERATIVE REPORT ¿¿DISSECTION WAS CARRIED DOWN THROUGH SKIN AND SUBCUTANEOUS TISSUE DOWN TO THE PRIOR FUSION MASS WHICH EXTENDED DOWN TO L4. THE HARRINGTON ROD WAS CAREFULLY IDENTIFIED. SUBPERIOSTEAL DISSECTION OF L4, LS, AND S1 WAS CARRIED OUT TO THE TIPS OF THE TRANSVERSE PROCESSES AND SACRAL ALA. ONCE THIS WAS PERFORMED, THE FUSION MASS WAS NOTED TO BE SOLID AND THE DISTAL PART OF THE HARRINGTON ROD WAS AMPUTATED AND REMOVED, REMOVING A LARGE HOOK FROM THE EPIDURAL SPACE. UTILIZING A HIGH-SPEED BUR, WE THEN REMOVED A LARGE AMOUNT OF THE FUSION MASS AND EXTENDED THIS DOWN THROUGH THE L4-5 FACET AND PARS INTER-ARTICULARIS BILATERALLY AT L4-5. WE THEN ENTERED THE EPIDURAL SPACE AND EXPOSED THE POSTERIOR ANNULUS, AND ACTUALLY PERFORMED BILATERAL ANNULOTOMIES AND EVACUATION OF THE DISKS. THIS ALLOWED US TO COMPLETELY MOBILIZE THE SEGMENT WHICH WAS ESSENTIALLY ANKYLOSED AND SEVERELY DEGENERATIVE. THE DISK WAS ENTERED AND ALL THE DISK WAS EVACUATED. THE END-PLATES WERE CARRIED DOWN TO RAW BLEEDING CORTICAL CANCELLOUS BONE. THIS ALLOWED US TO THEN CLOSE THE INTRAPEDICULAR DISTANCE TO PREPARE FOR CORRECTIVE LUMBAR CEMENT PETERSON OSTEOTOMY. WE INSERTED THE PEEK CAGE AT THE L4-5 INTERSPACE, MOVING IT ANTERIORLY. PRIOR TO DOING THIS, WE HAD IDENTIFIED THE PEDICLES AT L4, L5, AND S1 UNDER BIPLANAR FLUOROSCOPY AND INSERTED SCIENTIX TOP-LOADING PEDICULAR SCREWS. THESE WERE UTILIZED TO BOTH DISTRACT AND THEN SUBSEQUENTLY COMPRESS THE L4-5. THIS WAS THEN REPEATED THROUGH THE LS-S1. AGAIN, LARGE AMOUNTS OF BONE WERE REMOVED BILATERALLY FROM REMOVING THE PARS INTER-ARTICULARIS AS WELL AS THE JOINTS AT LS-81 BILATERALLY, AND DOING A COMPLETE FORAMINOTOMY AND OSTEOTOMIZING THIS WHOLE SEGMENT OF THE SPINE. THEN, AFTER DOING BILATERAL ANNULOTOMIES AND RESECTION OF THE POSTERIOR LONGITUDINAL LIGAMENT, AS WELL AS EVACUATION OF THE DISKS, THIS ALLOWED US TO APPLY A COMPRESSIVE COMPONENT TO CLOSE THE INTRAPEDICULAR DISTANCE. THIS ALLOWED US TO CARRY OUT A CEMENT PETERSON OSTEOTOMY TO CORRECT THE DEFORMITY AND CREATE LUMBAR LORDOSIS AND CORRECT SAGITTAL ALIGNMENT. AN APPROPRIATE SIZE CAGE WAS INSERTED WHICH HAD BEEN PACKED AGAIN WITH BONE MORPHOGENIC PROTEIN, FREEZE-DRIED CORTICAL CANCELLOUS BONE GRAFT, AS WELL AS BONE GRAFT FROM THE OSTEOTOMIES. ONCE THIS WAS PERFORMED, A ROD WAS THEN CONTOURED TO RESTORE THE SAGITTAL ALIGNMENT OF THE LUMBAR LORDOSIS, CLOSING THE INTRAPEDICULAR DISTANCE AND SETTING TO THE MAXIMUM TIGHTNESS AND CORRECT FOR THE SAGITTAL IMBALANCE. THIS ALLOWED US TO PLACE HER LUMBAR SPINE TO A MORE PHYSIOLOGICAL POSITION. THE NERVE ROOTS WERE CAREFULLY EXPLORED AFTER TIGHTENING THE ROD INTO POSITION, AND IT WAS FELT THAT THE PEDICLES WERE NOT ENCROACHING UPON ANY OF THE NERVE ROOTS AND THERE WAS ADEQUATE ROOM FOR THE NERVE ROOT ON EITHER SIDE. CAREFUL HEMOSTASIS WAS OBTAINED. ¿¿ IT WAS REPORTED THAT THE PATIENT LOST 1000CC OF BLOOD INTRA-OPERATIVELY AND POST OPERATIVELY RECEIVED THREE UNITS OF BLOOD. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT FOR HEMODYNAMIC MONITORING. THE PATIENT ALSO PRESENTED WITH A POST-OPERATIVE TACHYCARDIA. POST OPERATIVELY, THE PATIENT UNDERWENT A MRI SCAN WHICH SHOWED A POST OPERATIVE SEROMA/HEMATOMA AT L5- S1 LEVEL THAT DID HAVE SOME THECAL EFFACEMENT. ASPIRATED UNDER RADIOGRAPHIC GUIDANCE WAS CONDUCTED IN WHICH 40CC OF HEMATOMA WAS EVACUATED. THE PATIENT EXPERIENCED SOME RELIEF. CULTURES TAKEN OVER THREE DAYS WERE NEGATIVE. ON (B)(6) 2007, 3 DAYS POST OP, THE PATIENT PRESENTED WITH RIGHT LEG, HIP PAIN WITH AN UNRESOLVED SEROMA. THE PATIENT UNDERWENT SURGERY FOR IRRIGATION AND DEBRIDEMENT AND EVACUATION OF HEMATOMA. PER THE OPERATIVE REPORT ¿¿THERE WAS A HEMATOMA IDENTIFIED UNDER THE FASCIA. WE DID SEND ALSO CULTURES FROM THIS INTRAFASCIAL FLUID (NEGATIVE). THE HEMATOMA WAS METICULOUSLY REMOVED FROM AROUND THE THECAL SAC. WE AGAIN MADE SURE THAT WE HAD A FULL AND COMPLETE DECOMPRESSION BY EVALUATING ALL THE GUTTERS AND CORNERS UNDER THE LAMINA. THERE WAS NO IMPINGEMENT. THERE WAS NO OBVIOUS COMPRESSION ON THE DURA OTHER THAN FROM THE HEMATOMA¿¿ NO PATIENT COMPLICATIONS WERE REPORTED. ON (B)(6) 2007, THE PATIENT WAS DISCHARGED FROM HOSPITAL. ON (B)(6) 2008, THE PATIENT PRESENTED WITH THE POSTOPERATIVE DIAGNOSIS OF RETAINED HARRINGTON RODS. PER THE OPERATIVE REPORT A ¿¿SUBPERIOSTEAL DISSECTION WAS THE CARRIED OUT, EXPOSING THE FUSION MASS AS WELL AS THE HARRINGTON ROD AND THE HOOK. THE ROD THEN WAS MOBILIZED, UTILIZING OSTEOTOMES TO REMOVE PART OF THE FUSION MASS THAT WAS GROWING IN AND AROUND THE HOOK. THE ROD WAS MOBILIZED AND SLIGHTLY ELEVATED AND UTILIZING A HIGH SPEED CARBIDE TIP, THE ROD WAS DIVIDED. THE ROD WAS THEN LEVERED, AND THE HOOK WAS REMOVED WITHOUT ANY DIFFICULTY. THE REMAINING ROD WAS THEN GRASPED FIRMLY AND REMOVED AND SLID OUT OF THE SPINE¿¿ NO PATIENT COMPLICATIONS WERE REPORTED. ON (B)(6) 2008, THE PATIENT UNDERWENT A CERVICAL SPINE MRI WHICH DEMONSTRATED MULTILEVEL DEGENERATIVE DISC DISEASE RESULTING IN CANAL STENOSIS; DISC BULGES AT C4-5 AND C6-7 WHICH MAY HAVE TOUCHED THE VENTRAL SPINAL CORD WITHOUT DEFORMITY; MULTILEVEL NEURAL FORAMINAL NARROWING OR STENOSIS ¿ MOST PRONOUNCED AT THE LEFT AT C5-6 AND ALSO PROMINENT ON THE LEFT > RIGHT AT C6-7. THERE WERE NO ACUTE OSSEOUS ABNORMALITIES NOTED. ON (B)64) 2009 THE PATIENT PRESENTED WITH DECREASED BALANCE AND UNDERWENT A BRAIN MRI WHICH DEMONSTRATED NORMAL BRAIN WITHOUT GADOLINIUM AND MILD HYPEROSTOSIS FRONTALIS INTERNA. THE PATIENT ALSO PRESENTED WITH BUTTOCK PAIN AND UNDERWENT A MIR OF THE HIPS AND OSSEOUS PELVIS WHICH SHOWED DEGENERATIVE CHANGES BILATERAL HIPS. THERE WAS NO OCCULT FRACTURE OR AVN. THERE WAS A SUGGESTION OF MILD BURSITIS ABOUT THE GRATER TROCHANTERIC BURSAL REGION. ON (B)(6) 2009, THE PATIENT PRESENTED WITH NECK PAIN AND UNDERWENT A CERVICAL SPINE MRI WHICH DEMONSTRATED C6-7 DISC BULGE WITH BILATERAL LATERAL RECESS AND FORAMINAL PROTRUSIONS WITH LEFT GREATER THAN RIGHT NARROWING OF THE LATERAL RECESS AND NEURAL FORAMEN. THERE WAS NO CORD COMPRESSION. THERE WAS NARROWING OF THE LEFT LATERAL RECESS AND LEFT FORAMEN AT C5-6 MOSTLY DUE TO UNCOVERTEBRAL JOINT HYPERTROPHY. ON 28 FEB 2011 THE PATIENT PRESENTED WITH PAIN AND THE PREOPERATIVE DIAGNOSIS OF PSEUDOARTHROSIS AT L3-L4. THE PATIENT UNDERWENT SURGERY WHICH CONSISTED OF AN ANTERIOR LUMBAR FUSION THROUGH A TRANSPOSASE APPROACH WITH ANTERIOR INTERNAL FIXATION AND INSERTION OF PEEK CAGE. AP AND LATERAL FLUOROSCOPY WAS UTILIZED FOR PLACEMENT. NO PATIENT COMPLICATIONS WERE REPORTED. ON (B)(6) 2011, THE PATIENT UNDERWENT A LUMBAR SPINE CT WHICH DEMONSTRATED MILD SCOLIOTIC CURVE OF THE MID TO UPPER LUMBAR SPINE CO NVEX TO THE LEFT WITHOUT COMPRESSION FRACTURE. HARDWARE APPEARED INTACT AND IN PLACE. ON (B)(6) 2011, THE PATIENT PRESENTED WITH RIGHT LOWER EXTREMITY PAIN WITH THE PRE-OPERATIVE DIAGNOSIS OF LUMBAR SPINAL STENOSIS WITHOUT CLAUDICATION AND UNDERWENT A L3-4 ANTERIOR SPINAL FUSION WITH INSTRUMENTATION AND THROUGH AN XLIF APPROACH WITH CAGE IMPLANT AND SCREW PLACEMENT ALONG WITH BONE MORPHOGENIC PROTEIN AND ALLOGRAFT FUSION. NO PATIENT COMPLICATIONS WERE REPORTED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM HOSPITAL. ON (B)(6) 2011, THE PATIENT UNDERWENT A CT OF THE PELVIS INCLUDING S1 JOINTS WHICH DEMONSTRATED SCLEROTIC CHANGE ABOUT THE S1 JOINTS. ON (B)(6) 2012, THE PATIENT PRESENTED WITH NECK PAIN UNDERWENT A CERVICAL SPINE MRI WHICH SHOWED C4-5 DISC BULGE AND MOLD RIGHT NEURAL FORAMINAL STENOSIS SECONDARY TO UNICINATE SPUR AND MODERATE LEFT C5-6 NEURAL FORAMINAL STENOSIS AND UNICINATE SPUR. ON (B)(6) 2013, THE PATIENT PRESENTED WITH LEFT HIP PAIN AND UNDERWENT LEFT HIP XRAYS WHICH SHOWED MILD ARTHRITIC CHANGES ABOUT THE GREATER TROCHANTER OF THE FEMUR AND ACETABULUM AND MILD DEGENERATIVE CHANGES TO THE LEFT SACROILIAC JOINT. ON (B)(6) 2013, THE PATIENT PRESENTED WITH LOW BACK PAIN AND UNDERWENT A LUMBAR SPINE MRI WHICH DEMONSTRATED A MILD BULGING ANNULUS OF L4/5 WITH MILD TRANSVERSE SPINAL STENOSIS ON THE RIGHT; SATISFACTORY ALIGNMENT OF PEDICLE SCREWS AND POSTERIOR RODS AT L4/5 AND L5/S1; NO DISC DISPLACEMENT NOTED. NO ACUTE OSSEOUS ABNORMALITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 458146 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M111057AAE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |