INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2013-00994
- Event Type
- Injury
- Date Received
- April 11, 2013
- Report Date
- February 22, 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)(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)(6). (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) 2005: PATIENT UNDERWENT AP AND LATERAL VIEWS OF THE LUMBOSACRAL SPINE. IMPRESSION: INTERVAL LAMINECTOMY AND POSTERIOR SPINAL FIXATION AT L5-S1. ON (B)(6) 2005: THE PATIENT HAVING A HISTORY OF BACK PAIN AND LEFT LEG PAIN WAS ADMITTED IN THE HOSPITAL WITH PREOPERATIVE DIAGNOSIS: L5-S1 SPONDYLOLISTHESIS, AND UNDERWENT THE FOLLOWING PROCEDURES: TRANSVERSE LUMBAR INTERBODY FUSION L5-S1. USING PEAK INSTRUMENTATION, POSTERIOR INTERPEDICULAR FIXATION LS-SL, INTERBODY FUSION USING BONE MORPHOGENIC PROTEIN AND LOCAL AUTOGRAFT, GILL LAMINECTOMY, POSTERIOR LUMBAR INTERBODY FUSION USING PEAK CAGES AND POSTERIOR SEGMENTAL INSTRUMENTATION LS-SL. PER-OP NOTES: "THE PREVIOUSLY HARVESTED AUTOGRAFT WAS REPAIRED WITH A BONE MILL. THIS WAS IMPACTED INTO THE INTERBODY SPACE AT 5-1 FOLLOWED BY BONE MORPHOGENIC PROTEIN. A PEAK CAGE 11 X 26 WAS THEN FILLED WITH BMP AND IMPACTED IN THE TRACT, AFTER BOTH THE L5 AND S1 NERVE ROOT HAD BEEN CAREFULLY RETRACTED. AT THE CONCLUSION OF THIS, A THROMBIN SOAKED GELFOAM SQUARE WAS PLACED OVER THE DEFECT. THIS WAS DONE WITH FLUOROSCOPIC GUIDANCE TO ENSURE GOOD CAGE POSITION." ON (B)(6) 2005: PATIENT GOT DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2005: PATIENT UNDERWENT CT LUMBAR SPINE. IMPRESSION: MINIMAL ANTEROLISTHESIS OF L5 ON S1 WITH MILD LEVOSCOLIOSIS NOTED AT L5-S1. POST-SURGICAL CHANGES ASSOCIATED WITH PRIOR LAMINECTOMY AND SPINAL FUSION AT L5-S1. DEGENERATIVE CHANGES INVOLVING BOTH 81-JOINTS, LEFT GREATER THAN RIGHT. ON (B)(6) 2005: PATIENT UNDERWENT LUMBAR MYELOGRAM AND POST MYELOGRAPHIC CT. IMPRESSION: MINIMAL ANTEROLISTHESIS OF L5 ON S1, STATUS POST LAMINECTOMY AND FUSION. SURGICAL GRAFT MATERIAL AT THE L5-S1 DISK SPACE EXTENDS BEYOND THE LEFT POSTEROLATERAL ASPECT OF THE VERTEBRAL BODY. THE GRAFT MATERIAL INDENTS THE THECAL SAC AND COMPRESSES THE LEFT S1 NERVE ROOT. THERE IS PARTIAL CUT-OFF OF THE LEFT S1 NERVE ROOT ON MYELOGRAM. MILD DEGENERATIVE CHANGES, AT L2-3 AND L3-4 AS DESCRIBED. ON (B)(6) 2005: PATIENT PRESENTED FOR PRE-PROCEDURE PHYSICAL EXAMINATION, WITH COMPLAINTS OF BACK PAIN, WEAKNESS AND NUMBNESS. ON (B)(6) 2005: PATIENT UNDERWENT X-RAY OF LUMBO-SACRAL SPINE (SINGLE AP VIEW). FINDINGS: THERE BILATERAL LAMINECTOMIES AT L5. PAIRED POSTERIOR FIXATION RODS AND TRANSPEDICULAR SCREWS ARE SEEN AT L5-S1. MIDLINE POSTERIOR STAPLES ARE SEEN. THERE IS NO LATERAL VIEW AVAILABLE TO ASSESS ALIGNMENT. THERE ARE NO OTHER GROSS ABNORMALITIES IDENTIFIED. ON (B)(6) 2005: THE PATIENT HAD TO UNDERGO A RE-EXPLORATION, I.E, A REVISION SURGERY, 12 WEEKS POST-OP HIS INITIAL SURGERY ON (B)(6) 2005. BY 3 WEEKS POSTOPERATIVELY, THE PATIENT HAD BACK AND LEG PAIN AND CT SCAN AT THAT TIME SHOWED REASONABLE CONSTRUCT POSITION. HE IMPROVED SLIGHTLY WITH THE BACK PAIN AND THEN BEGAN TO NOTICE ALMOST EXCLUSIVELY LEFT LEG PAIN. HE WAS SUBSEQUENTLY SENT FOR A CT MYELOGRAPHY WHICH SUGGESTED BACK-OUT OF THE INTERBODY CAGE WITH ECTOPIC OSSIFICATION DISPLACING THE S1 NERVE ROOT. DESPITE SELECTIVE NERVE ROOT BLOCKADE AND ANALGESICS, HE CONTINUED TO BE PAINFUL. HENCE, RE-EXPLORATION WAS INDICATED. PREOPERATIVE DIAGNOSIS: LEFT S1 RADICULOPATHY. PROCEDURE: EXPLORATION LEFT L5-S1 DISK SPACE, FORAMINOTOMY FACETECTOMY LEFT L5-S1, REMOVAL INTERBODY CAGE, RE-FUSION LS-S1, REMOVAL AND SUBSEQUENT REINSERTION OF SPINAL HARDWARE LEFT SIDE. PER-OP NOTES: "PULSE LAVAGE WAS USED TO THOROUGHLY IRRIGATE THE FIELD AND THE DISK SPACE AGAIN EXPLORED. FLUOROSCOPIC GUIDANCE WAS USED. THE DISK SPACE WAS AGAIN PREPARED WITH A CURETTE AND FILLED WITH BONE MORPHOGENIC PROTEIN AND ALLOGRAFT. SCREWS WERE THEN REINSERTED ON THE LEFT SIDE. A 6.5 X 45 WAS USED LEFT L5 AND A 7.5 X 40 USED LEFT S1. ASIDE FROM FLUOROSCOPY, THE LATERAL RECESSES WERE PALPATED DURING SCREW INSERTION. EMG IMPEDANCE REVEALED EXCELLENT THRESHOLDS AS WELL. A ROD WAS THEN PLACED AND TIGHTENED WITH THE APPROPRIATE COUNTER TORQUE MEASURES. HEMOSTASIS WAS OBTAINED WITHOUT THE USE OF SUCTION. THE WOUND WAS QUITE DRY AT CLOSURE." ON (B)(6) 2005: PATIENT UNDERWENT X-RAY OF LUMBO-SACRAL SPINE (AP, LATERAL VIEWS). FINDINGS: PAIRED POSTERIOR FIXATION RODS TRANSPEDICULAR SCREWS ARE SEEN AT L5-S1. BILATERAL LAMINECTOMIES ARE SEEN AT L5-S1. THERE IS NO SPONDYLOLISTHESIS. ALIGNMENT IS SATISFACTORY. MIDLINE POSTERIOR SKIN STAPLES ARE SEEN. NO OTHER GROSS ABNORMALITIES ARE SEEN. ON (B)(6) 2005: PATIENT GOT DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2005: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2005: PATIENT UNDERWENT CT SCAN OF LUMBAR SPINE. IMPRESSION: IMPINGEMENT OF THE LEFT L5-S1 LATERAL RECESS BY BONE GRAFT. NO CHANGE COMPARED TO PRIOR STUDY DATED (B)(6) 2005. ON (B)(6) 2006: THE PATIENT HAVING A HISTORY OF INTRACTABLE LEFT LOWER EXTREMITY PAIN, HAD TO UNDERGO REVISION SURGERY FOR HARDWARE REMOVAL. HE IS STATUS POST PLIF. CT SCAN SUGGESTED SOLID FUSION WITH A POSTERIOR BULGE INTERBODY GRAFT. IN VIEW OF INTRACTABLE PAIN, THE HARDWARE REMOVAL AND FORAMINOTOMIES AS WELL AS FUSION EXPLORATION WERE INDICATED. PER OP-NOTES: "THE OLD INCISION WAS OPENED AND EXTENDED SLIGHTLY PROXIMALLY. DISSECTION WAS CARRIED DOWN TO THE MIDLINE. SELF-RETAINING RETRACTORS WERE INSERTED. LATERAL SPINAL DISSECTION FOLLOWED WITH EXPOSURE OF THE HARDWARE BILATERALLY. FIBROSIS WAS NOTED. A BURSA WAS ENCOUNTERED, AND THIS WAS CULTURED." ON (B)(6) 2006: PATIENT GOT DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2009: PATIENT PRESENTED AT OFFICE WITH COMPLAINS OF BACK PAIN, GROIN PAIN, AND FAMILIAR LEFT LOWER EXTREMITY PAIN, AND UNDERWENT X-RAY OF LUMBO-SACRAL SPINE (AP, LATERAL, FLEXION, AND EXTENSION VIEWS OF THE LUMBAR SPINE) FOR LOW BACK PAIN. IMPRESSION: NO SIGNIFICANT BONY ABNORMALITY. ON (B)(6) 2010: PATIENT PRESENTED FOR OFFICE VISIT WITH COMPLAINTS OF PAIN IN HIS LEFT KNEE ("I'VE TORN MY MENISCUS AGAIN") AND PAIN IN THE LOWER BACK RADIATING TO THE GROIN AREA, LEFT MORE THAN RIGHT. HE ALSO REPORTED THAT HIS ARM AND LEG STARTED "SHAKES". PATIENT'S PHYSICAL EXAMINATION REVEALED PAIN-RELATED WEAKNESS IN THE RIGHT HAND GRIP. HIS LUMBAR SPINE IS DIFFUSELY TENDER TO PALPATION WITH DECREASED ROM. SENSATION: HYPOESTHESIA IN THE LEFT LEG AND FOOT AND IN S1 DERMATOMAL DISTRIBUTION. HE WALKS WITH A LIMP. COORDINATION IS PRESERVED. ON (B)(6) 2010, (B)(6) 2011: PATIENT PRESENTED FOR OFFICE VISIT WITH COMPLAINTS OF INTENSE PAIN IN THE LOWER BACK, LEFT KNEE AND A SEVERE BURNING SENSATION IN HIS LEFT FOOT. PATIENT'S PHYSICAL AND NEUROLOGICAL EXAMINATIONS WERE ESSENTIALLY WITHOUT NEW FINDINGS. HIS LUMBAR SPINE IS DIFFUSELY TENDER TO PALPATION WITH DECREASED ROM. VERY BRISK REFLEXES IN THE LOWER EXTREMITIES. SENSATION: HYPOESTHESIA IN THE LEFT LEG AND FOOT AND IN S1 DERMATOMAL DISTRIBUTION. HE WALKS WITH A LIMP. COORDINATION IS PRESERVED. ON (B)(6) 2011: PATIENT PRESENTED FOR OFFICE VISIT WITH COMPLAINTS OF PAIN IN THE KNEES, LOWER BACK, LEGS, RIGHT ARM AND WRIST. HE REPORTED A BURNING SENSATION IN THE SOLES OF HIS FEET. ON (B)(6) 2011: PATIENT PRESENTED FOR OFFICE VISIT WITH COMPLAINTS OF SEVERE LUMBAR RADICULOPATHY, FREQUENT URINARY INCONTINENCE, AND PAIN AND BURNING SENSATION IN THE SOLES OF HIS FEET, LEFT MORE THAN RIGHT. ON (B)(6) 2011, (B)(6) 2012, (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT WITH COMPLAINTS OF CONSTANT PAIN IN THE LOWER BACK RADIATING DOWN TO HIS BUTTOCKS, KNEES AND FEET (LEFT MORE THAN RIGHT). HE HAS A BURNING SENSATION IN THE FEET. PATIENT'S PHYSICAL EXAMINATION REVEALED THAT HIS LUMBAR SPINE IS TENDER TO PALPATION WITH DECREASED ROM. REFLEXES ARE VERY BRISK IN THE LOWER EXTREMITIES WITH UN-SUSTAINED CLONUS, WORSE ON THE LEFT. SENSATION IS DECREASED IN THE LEFT LEG AND BOTH FEET. GAIT IS ANTALGIC. COORDINATION IS PRESERVED. ON (B)(6) 2012: PATIENT PRESENTED WITH COMPLAINTS OF SEVERE PAIN IN THE LOWER BACK, RADIATING DOWN TO THE LEGS. HE HAS A LONG HISTORY OF SEVERE LUMBAR RADICULOPATHY AND CHRONIC PAIN SYNDROME. THE PATIENT UNDERWENT NCS-EMG -LOWER EXTREMITIES (NERVE CONDUCTION AND ELECTROMYOGRAPHY) TEST FOR GETTING EVALUATED FOR LUMBAR OR LUMBOSACRAL RADICULOPATHY AND/ OR PERIPHERAL NEUROPATHY. CONCLUSION: THIS STUDY IS ABNORMAL AND INDICATIVE OF CHRONIC S1 MORE THAN L5 RADICULOPATHY, RIGHT MORE THAN LEFT. H-REFLEX IS ABNORMAL DUE TO PROLONGATION OF THE RESPONSE ON THE RIGHT. EMG SHOWED INCREASED INSERTIONAL ACTIVITY, LARGE AMPLITUDE POSITIVE SHARP WAVES AND FIBRILLATIONS, POLYPHASIC MUAPS AND DECREASED RECRUITMENT PATTERN OF THE LOWER LUMBAR PARASPINALS. DEGENERATIVE DISC DISEASE OR/AND TRAUMA ARE THE MOST PROBABLE CAUSES OF THESE FINDINGS. ON (B)(6) 2012: PATIENT PRESENTED FOR OFFICE VISIT WITH COMPLAINTS OF SEVERE PAIN IN THE LOWER BACK RADIATING TO THE LEG; LUMBAR RADICULOPATHY AND CHRONIC PAIN SYNDROME. A MONTH AGO HE HAD EMG/NCV STUDY OF HIS LOWER EXTREMITIES WITH REVEALED CHRONIC S11 MORE THAN L5 RADICULOPATHY, ON THE RIGHT MORE THAN ON THE LEFT. PATIENT'S PHYSICAL EXAMINATION REVEALED THAT HIS LUMBAR SPINE IS TENDER TO PALPATION WITH DECREASED ROM. REFLEXES ARE VERY BRISK IN THE LOWER EXTREMITIES WITH UN-SUSTAINED CLONUS, WORSE ON THE LEFT. SENSATION IS DECREASED IN THE LEFT LEG AND BOTH FEET. GAIT IS ANTALGIC. COORDINATION IS PRESERVED. ON (B)(6) 2012: PATIENT PRESENTED FOR OFFICE VISIT WITH COMPLAINTS OF SEVERE PAIN IN THE LOWER BACK RADIATING TO THE LEGS AND OTHER SYMPTOMS OF HIS CHRONIC PAIN SYNDROME. THE PHYSICIAN NOTED A MASS ON THE MEDIAN ASPECT OF HIS LEFT KNEE AND THE PATIENT REPORTS THAT PAIN FROM THIS AREA GOES UNDER THE KNEE CAP. ON (B)(6) 2012: PATIENT PRESENTED FOR OFFICE VISIT WITH COMPLAINTS OF WIDESPREAD PAIN IN THE NECK, LOWER BACK, LEGS AND FEET. ON (B)(6) 2013: PATIENT UNDERWENT MRI OF HIS LUMBAR SPINE, PERFORMED IN SAGITTAL AND TRANSVERSE PLANES. IMPRESSION: POSTOPERATIVE CHANGES AT L5-S1 WITH LEFT SIDED FORAMINAL NARROWING RELATED TO DISC BULGING, SPONDYLOLISTHESIS AND POSTERIOR FACET ARTHRITIS. L4-5 SHOWS DEGENERATIVE CHANGE WITH MILD FORAMINAL NARROWING AS WELL. PATIENT UNDERWENT MRI OF HIS CERVICAL SPINE, PERFORMED IN SAGITTAL AND TRANSVERSE PLANES. IMPRESSION: RIGHT SIDED FORAMINAL NARROWING AT C3-4 ON A DEGENERATIVE BASIS. C5-6 SHOWS MILD FORAMINAL NARROWING AS WELL RELATED TO DEGENERATIVE CHANGE.
IT WAS REPORTED THAT ON (B)(6)-2005, THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION ON THE LUMBAR SPINE FROM VERTEBRAE L5-S1. HE WAS IMPLANTED WITH RHBMP-2/ACS. POST SURGERY, HE HAD PROGRESSIVELY WORSENING PAIN IN HIS LOW BACK, WITH ASSOCIATED RADICULOPATHY AND WEAKNESS IN HIS LOWER EXTREMITIES. SEVERE PAIN AND SYMPTOMS COMPELLED THE PATIENT TO UNDERGO REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156326 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | M114001AAC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |