INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2014-02912
- Event Type
- Injury
- Date Received
- June 25, 2014
- Report Date
- September 5, 2017
- 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).
(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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LUMBAR FUSION PROCEDURE AT L3 TO L4 USING RHBMP-2/ACS ON (B)(6), 2006. PATIENT'S P OST-OPERATIVE PERIOD HAS BEEN MARKED BY CHRONIC BACK PAIN. RADIOGRAPHIC IMAGING CONDUCTED ON (B)(6), 2012 REVEALS A NEUROCOMPRESSIVE LESION AT THE SURGERY SITE. PATIENT CONTINUES TO EXPERIENCE SEVERE AND UNRELENTING PAIN THAT RADIATES INTO HER RIGHT LOWER EXTREMITY.
IT WAS REPORTED THAT ON: (B)(6) 2006: PATIENT UNDERWENT MRI OF THE LUMBAR SPINE. IMPRESSION: FINDINGS OF DEVELOPING DEGENERATIVE DISCS, PARTICULARLY AT L3-4 WITH POST SURGICAL CHANGES FROM L4 DOWN TO S1. NOTHING ACUTE IS DEMONSTRATED. ON (B)(6) 2006: PATIENT UNDERWENT CT OF LUMBAR SPINE. IMPRESSION: THERE HAS BEEN PREVIOUS ANTERIOR AND POSTERIOR FUSION AT L4-5 AND L5-S1 WITH FUSION CAGES ANTERIORLY AT BOTH DISCS AND POSTERIOR FUSION WITH PEDICLE SCREWS AT L4 AND S1. THERE IS SOLID ANTERIOR AND POSTERIOR FUSION AT L4-5 AND L5-S1. AT L3-4 THERE IS DISC SPACE NARROWING. THERE IS POSTERIOR BULGING OF THE DISC. THERE IS A LEFT FORAMINAL HERNIATION. POSTERIORLY AT L3-4 THE FACET JOINTS ARE INCREASED IN SPACE AND OPENED TO SOME DEGREE WITH VACUUM PHENOMENON AND WITH BONE SCLEROSIS BILATERALLY ON WITHER SIDE OF THE FACET ARTICULATION. ON (B)(6) 2006: PATIENT PRESENTED WITH PRE-OP DIAGNOSIS: L3-4 DEGENERATIVE DISC DISEASE, LUMBAGO, STATUS POST L4-5 AND L5-S1 ANTERIOR POSTERIOR LUMBAR SPINE FUSION. PROCEDURE: L4 AND S1 BILATERAL PEDICLE SCREW INSTRUMENTATION HARDWARE REMOVAL, BILATERAL L3 LAMINECTOMIES AND LEFT L3-4 FACETECTOMY, L3-4 FUSION WITH TRANSVERSE POLY ETHYL-ETHYL KETONE CAGE, BILATERAL L3-4 PEDICLE SCREW INSTRUMENTATION AND BILATERAL PARASPINAL FUSION WITH CANCELLOUS BONE ALLOGRAFT AND AUTOGRAFT. THE PROCEDURE WAS PERFORMED UTILIZING INTRAOPERATIVE EMG MONITORING AND UNDER MICROSCOPE MAGNIFICATION. PEROP: BILATERAL L4 PEDICLE SCREWS WERE REMOVED WITHOUT COMPLICATIONS FOLLOWED BY INSERTION OF THE ESCALLOPED 7 MM IN DIA PEDICLE SCREWS THROUGH THE PREVIOUS TRANSPEDICULAR TRACKS. THE POLY ETHYL- ETHYL KETONE CAGE WAS FILLED UP WITH A SPONGE WITH BMP. THE PEDICLE SCREWS BILATERALLY AT THE L3-4 LEVEL WERE CONNECTED WITH A ROD. ON (B)(6) 2007: PATIENT UNDERWENT THREE VIEWS OF LUMBOSACRAL SPINE. IMPRESSION: THERE ARE POSTERIOR TRANSPEDICULAR SCREWS AT THE LEVELS OF L3-L4 WITH METALLIC CAGE DISC PROSTHESIS AT L4-5 AND L5-S1. SCREWS ARE ALSO NOTED IN BOTH SIDES OF L5. THERE IS DENSE MATERIAL SURROUNDING THE SURGICAL SITE AND THE ALIGNMENT OF THE LUMBOSACRAL SPINE IS MAINTAINED. THERE ARE ALSO SURGICAL CLIPS ANTERIOR TO SPINE. THE VERTEBRAL BODY HEIGHTS ARE MAINTAINED. ON (B)(6) 2007: THE PATIENT PRESENTED FOR FOLLOW UP. ON (B)(6) 2007: THE PATIENT PRESENTED FOR FOLLOW UP. HE WAS HAVING ANXIETY DEPRESSION. ON (B)(6) 2007: THE PATIENT PRESENTED FOR FOLLOW UP. ON (B)(6) 2008: THE PATIENT PRESENTED WITH CHRONIC PAIN. IMPRESSION: POSTOP SPINE, NORMAL ALIGNMENT, DEGENERATIVE JOINT DISEASE. ON (B)(6) 2008: THE PATIENT PRESENTED FOR FOLLOW UP. ON (B)(6) 2009: THE PATIENT PRESENTED WITH HIGH PRETENSION AND DEGENERATIVE DISC DISEASE. PATIENT VISITED FOR FOLLOW UP WITH HEADACHE AND BACK PAIN. ON (B)(6) 2009: THE PATIENT PRESENTED FOR FOLLOW UP. ON (B)(6) 2009: PATIENT VISITED FOR FOLLOW UP WITH CHRONIC BACK PAIN. ON (B)(6) 2009: THE PATIENT PRESENTED WITH BACK PAIN. ON (B)(6) 2009: THE PATIENT UNDERWENT X RAYS OF LUMBOSACRAL SPINE. IT SHOWED INTERNAL FIXATION AT DIFFERENT LEVELS IN THE LOWER LUMBAR SPINE. POST TWO BACK SURGERIES WAS PERFORMED. ON (B)(6) 2009: PATIENT VISITED FOR FOLLOW UP. ON (B)(6) 2009: THE PATIENT PRESENTED WITH ISCHEMIC HEART DISEASE. ON (B)(6) 2009: THE PATIENT PRESENTED FOR FOLLOW UP. ON (B)(6) 2009: PATIENT VISITED FOR FOLLOW UP. ON (B)(6) 2010: THE PATIENT PRESENTED FOR FOLLOW UP. ON (B)(6) 2009: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2009: THE PATIENT PRESENTED WITH HYPERTENSION, HYPERCHOLESTEROLEMIA. ON (B)(6) 2009: PATIENT VISITED FOR FOLLOW UP WITH CHRONIC BACK PAIN. ON (B)(6) 2009: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2009: PATIENT VISITED FOR FOLLOW UP WITH BACK PAIN. ON (B)(6) 2009: THE PATIENT UNDERWENT MAMMOGRAM DIAGNOSIS. SHE WAS HAVING CHRONIC BACK PAIN ON (B)(6) 2009: THE PATIENT UNDERWENT BILATERAL DIGITAL MAMMOGRAPHY. ON (B)(6) 2009: THE PATIENT UNDERWENT MAMMOGRAM UNILATERAL DIAGNOSIS. IMPRESSION: ROUTINE MAMMOGRAPHIC FOLLOW UP IS RECOMMENDED. ON (B)(6) 2009: THE PATIENT UNDERWENT UDENDUM MAMMOGRAM. IMPRESSION: ROUTINE MAMMOGRAPHIC FOLLOW UP IS RECOMMENDED. ON (B)(6) 2009: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2010: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2010: PATIENT PRESENTED FOR FOLLOW UP WITH ITCHING IN EYES. ON (B)(6) 2010: PATIENT PRESENTED FOR FOLLOW UP WITH LOWER BACK PAIN AND STOMACH PAIN. ON (B)(6) 2010: PATIENT VISITED FOR FOLLOW UP WITH NAUSEA. ON (B)(6) 2010: PATIENT PRESENTED FOR FOLLOW UP. ON (B)(6) 2010: PATIENT PRESENTED FOR OFFICE VISIT, FOR SLEEP STUDY. ASSESSMENT: OBSTRUCTIVE SLEEP APNEA, BASELINE POLYSOMNOGRAM AND HY PERTENSION. ON (B)(6) 2010: PATIENT PRESENTED FOR OFFICE VISIT FOR DISABILITY DETERMINATIONS. ON (B)(6) 2010: PATIENT PRESENTED FOR OFFICE VISIT, SLEEP STUDY PERFORMED. ASSESSMENT: OBSTRUCTIVE SLEEP APNEA, BASELINE POLYSOMNOGRAM AND HYPERTENSION. ON (B)(6) 2010: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2010: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2010: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2010: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2010: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2011: PATIENT PRESENTED FOR FOLLOW UP WITH SINUS. ON (B)(6) 2011: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2011: PATIENT PRESENTED FOR FOLLOW UP WITH SNEEZING. ON (B)(6) 2011: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2011: THE PATIENT UNDERWENT MAMMOGRAPHIC DIAGNOSTIC. ON (B)(6) 2011: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2012: PATIENT PRESENTED FOR FOLLOW UP WITH JOINT PAIN. ON (B)(6) 2012: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2012: PATIENT UNDERWENT RIGHT SHOULDER 2 VIEWS. IMPRESSION: NEGATIVE FOR ACUTE ALLERGIES OF THE RIGHT SHOULDER. RIGHT KNEE 3 VIEWS. IMPRESSION: NEGATIVE FOR ACUTE BONE ABNORMALITIES. MILD OSTEOARTHRITIS. ON (B)(6) 2012: THE PATIENT PRESENTED FOR BILATERAL SCREENING DIGITAL MAMMOGRAPHY. (B)(6) STUDY WAS PERFORMED USING A HOLOGIC DEXA SCANER. ON (B)(6) 2012: THE PATIENT PRESENTED FOR SPINAL PAIN. ON (B)(6) 2012: PATIENT PRESENTED WITH CERVICAL NECK PAIN, TRAPEZIUS PAIN, LOWER BACK PAIN, AND HEIGHTENED PAIN ON THE RIGHT SIDE. ON (B)(6) 2012: THE PATIENT PRESENTED FOR SPINAL PAIN. ON (B)(6) 2012: PATIENT PRESENTED WITH COUGHING AND SNEEZING. ON (B)(6) 2012: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2012: PATIENT UNDERWENT MRI OF CERVICAL SPINE WITH AND WITHOUT CONTRAST. IMPRESSION: STATUS POST POSTERIOR DECOMPRESSION AND POSTERIOR SPINAL STABILIZATION AT L3-4, THERE IS A SMALL LEFT PARACENTRAL VENTRAL EXTRADURAL IMPRESSION THAT DOES NOT ENHANCE AND MAY REPRESENT A SMALL DISC OSTROPHYTE COMPLEX. THERE MAY HAVE BEEN A PARTIAL DISCECTOMY AND/ OR ANTERIOR INTERBODY FUSION AS WELL. THE CENTRAL CANAL IS PATENT AS ARE THE NEURAL FORMAINA. THERE IS NO EPIDURAL FLUID COLLECTION. STATUS POST ANTERIOR INTERBODY FUSION AT L4-5. THE CENTRAL CANAL AND NEURAL FORAMINA ARE PATENT. STATUS POST ANTERIOR INTERBODY FUSION AT L5-S1. THE CENTRAL AND NEURAL FORAMINA ARE PATENT. MILD DISC BULGE AT L2-3 WITHOUT CENTRAL CANAL OR FORAMINAL STENOSIS. MILD DEGENERATIVE FACET ARTHROSIS. MILD DEGENERATIVE DISC DISEASE IN THE LOWER THORACIC SPINE WITH DISC BULGES AT T9-10 AND T10-11. ON (B)(6) 2012: PATIENT PRESENTED WITH CHRONIC NECK PAIN AND BACK PAIN. ON (B)(6) 2012: PATIENT PRESENTED WITH FOLLOWING PREOP DIAGNOSES: LUMBAR FACET JOINT ARTHROPATHIES/ SYNDROME. POSTLUMBAR LAMINECTOMY PAIN SYNDROME WITH EPIDURAL FIBROSIS AND LUMBAR RADICULOPATHIES. LUMBAR DEGENERATIVE DISK DISEASES. FIBROMYALGIA, CERVICALGIA HEADACHES MORBID OBESITY, HYPERTENSION AND MITRAL VALVE PROLAPSE. PROCEDURE: DIAGNOSTIC BILATERAL LUMBOSACRAL FACET JOINT MEDIAL BRANCH NERVE BLOCK INJECTIONS AT L2, L3 AND L4 DORSAL PRIMARY RAMUS OF L5 SACRAL ALA AND S1. CONTRAST INJECTION. ON (B)(6) 2012: PATIENT PRESENTED FOR FOLLOW UP DUE TO CHRONIC NECK PAIN AND BACK PAIN. ON (B)(6) 2012: THE PATIENT PRESENTED FOR FOLLOW UP. ON (B)(6) 2012: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2012: PATIENT PRESENTED WITH PAIN IN BACK TO BASELINE. ON (B)(6) 2012: PATIENT PRESENTED WITH KNEE PAIN. ON (B)(6) 2012: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: RIGHT LUMBOSACRAL FACET JOINT SYNDROME WORSE THAN LEFT. POSTLUMBAR LAMINECTOMY PAIN SYNDROME WITH EPIDURAL FIBROSIS. LUMBAR RADICULOPATHIES DEGENERATIVE DISK DISEASES. FIBROMYALGIA, CERVICALGIA, HEADACHES, MORBID OBESITY, HYPERTENSION, AND MITRAL VALVE PROLAPSE. PROCEDURE: RADIOFREQUENCY THERMOCOAGULATION LESONING RHIZOTOMIES OF THE RIGHT LUBAR FACET JOINTS OF L3-4, L4-5 AND L5-S1 WITH THE MEDIAL NERVES OF L2, L3 AND L4 THE DORSAL PRIMARY RAMUS OF L5 SACRAL ALA AND SI UNDER FLUOROSCOPIC VISUALIZATION AS THE DESTRUCTIONS WERE PERFORMED AT THE MEDIAN BRANCH OF THE SPINAL NERVE INNERVATING THE FACET JOINTS. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW UP DUE TO LEFT LOW BACK PAIN GOING DOWN TO HER LEFT BUTTOCK AND HER LEFT POSTERIOR THIGH. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT WITH KNEE PAIN. PATIENT UNDER WENT A X-RAY OF KNEE. IMPRESSIONS: CONTUSION/BRUISE BILATERAL KNEES. AGGRAVATION OF UNDERLYING ARTHRITIS, BILATERAL KNEES. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW UP. ON (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW UP DUE TO RESIDUAL PAIN ON THE LEFT LOW BACK. ON (B)(6) 2013: PATIENT PRESENTED WITH FOLLOWING PREOP DIAGNOSIS: LEFT LUMBOSACRAL FACET JOINT SYNDROME WORSE THAN THE RIGHT. POST LUMBAR LAMINECTOMY PAIN SYNDROME. EPIDURAL FIBROSIS, NEUROGENIC CLAUDICATION. FIBROMYALGIA, CERVICALGIA, MORBID OBESITY, HYPERTENSION, MITRAL VALVE PROLAPSE, HEADACHES. PROCEDURE: RADIOFREQUENCY THERMOCOAGULATION LESONING RHIZOTOMIES OF THE LEFT LUMBAR FACET JOINTS OF L3-4, L4-5 AND L5-S1 WITH THE MEDIAL NERVES OF L2, L3 AND L4 THE DORSAL PRIMARY RAMUS OF L5 SACRAL ALA AND SI UNDER FLUOROSCOPIC VISUALIZATION AS THE DESTRUCTIONS WERE PERFORMED AT THE MEDIAN BRANCH OF THE SPINAL NERVE INNERVATING THE FACET JOINTS. ON (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW UP DUE TO LEFT LUMBAR PAIN. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW UP WITH JOINT PAIN. ON (B)(6)2013: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6)2013: PATIENT PRESENTED FOR FOLLOW UP. ON (B)(6) 2013: THE PATIENT PRESENTED FOR ROUTINE SCREENING. STABLE MAMMOGRAM WAS OBSERVED. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW UP, PATIENT SUFFERS FROM ALLERGIES AND ASTHMA. DIAGNOSIS: HYPERTENSION, ALLERGIC RHINITIS, EXTRINSIC ASTHMA AND DRUG ALLERGY. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2013: PATIENT PRESENTED WITH ASTHMA. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT SUFFERING WITH COUGHING AND SNEEZING. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT SUFFERING WITH HEADACHE. ON (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW UP DUE TO PAIN. EXAMINATION PERFORMED. IMPRESSION: LUMBAGO, LUMBOSACRAL FACET JOINT ANTHROPATHY, NEUROGENIC CLAUDICATION, LUMBAR MYOFASCIAL PAIN AND CHRONIC LUMBAR PAIN COMPLAINTS. ON (B)(6) 2012, (B)(6) 2013: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: BILATERAL LUMBOSACRAL FACET JOINT ARTHROPATHY/ SYNDROMES. POST LUMBAR LAMINECTOMY PAIN SYNDROME WITH EPIDURAL FIBROSIS. L3-4 ANTERIOR INTERBODY FUSION, L4-5 HARDWARE AND L5-S1 FUSION. FIBROMYALGIA, CERVICALGIA, HEADACHE, MORBID OBESITY, HYPERTENSION, MITRAL VALVE PROLAPSE. PROCEDURE: THERAPEUTIC BILATERAL LUMBOSACRAL FACET JOINT MEDIAL BRANCH NERVE BLOCK INJECTIONS AT L2, L3, L4 DORSAL PRIMARY RAMUS OF L5 SACRAL ALA AND S1. CONTRAST INJECTION UNDER FLUOROSCOPIC VISUALIZATION FOR NEEDLE PLACEMENT AND SPREAD OF THE MEDICATION VERIFICATION. ON (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW UP DUE TO PAIN. ASSESSMENT: LUMBAGO AND LUMBOSACRAL FACET JOINT ARTHROPATHY. ON (B)(6) 2013: PATIENT PRESENTED WITH FOLLOWING PREOP DIAGNOSIS: RIGHT LUMBOSACRAL FACET JOINT SYNDROME WORSE THAN THE LEFT. POST LUMBAR LAMINECTOMY PAIN SYNDROME. EPIDURAL FIBROSIS, NEUROGENIC CLAUDICATION. FIBROMYALGIA, CERVICALGIA, MORBID OBESITY, HYPERTENSION, MITRAL VALVE PROLAPSE, HEADACHES. PROCEDURE: RADIOFREQUENCY THERMOCOAGULATION LESONING RHIZOTOMIES OF THE RIGHT LUBAR FACET JOINTS OF L3-4, L4-5 AND L5-S1 WITH THE MEDIAL NERVES OF L2, L3 AND L4 THE DORSAL PRIMARY RAMUS OF L5 SACRAL ALA AND SI UNDER FLUOROSCOPIC VISUALIZATION AS THE DESTRUCTIONS WERE PERFORMED AT THE MEDIAN BRANCH OF THE SPINAL NERVE INNERVATING THE FACET JOINTS. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT DUE TO HEADACHE. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT SUFFERING WITH VOMITING AND NAUSEA. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT. REVIEW OF SYSTEMS: MUSCULOSKELETAL: POSITIVE FOR JOINT AND BACK PAIN. NEUROLOGICAL: POSITIVE FOR HEADACHE. IMPRESSION: PATIENT HAS LOWER BACK SYNDROME. PATIENT HAS CHRONIC DAILY HEADACHES. ON (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW UP DUE TO RIGHT LOW BACK AND BUTTOCK REGION. ON (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW UP WITH HEADACHE. ON (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW UP WITH HEADACHE. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6)2014: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: BILATERAL LUMBOSACRAL FACET JOINT ARTHROPATHIES, POST LUMBAR LAMINECTOMY PAIN SYNDROME, HYPERTENSION, MIGRAINES, LUMBAR RADICULOPATHIES, DEGENERATIVE DISC DISEASE, NEUROGENIC CLAUDICATION, FIBROMYALGIA, MORBID OBESITY, MITRAL VALVE PROLAPSE. PROCEDURE: THERAPEUTIC BILATERAL LUMBOSACRAL FACET JOINT MEDIAL BRANCH NERVE BLOCK INJECTIONS L2, L3, L4, DORSAL PRIMARY RAMUS OF L5, SACRAL ALA AND S1. CONTRAST INJECTION UNDER FLUOROSCOPIC VISUALIZATION FOR NEEDLE PLACEMENT AND SPREAD OF THE MEDICATIONS VERIFICATION.
IT WAS REPORTED THAT ON: (B)(6) 2006: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH L3-4 DEGENERATIVE DISC DISEASE, LUMBAGO, STATUS POST L4-5 AND L5-S1 ANTERIOR-POSTERIOR LUMBAR SPINE FUSION AND UNDERWENT THE FOLLOWING PROCEDURES: L4 AND S1 BILATERAL PEDICLE SCREW INSTRUMENTATION HARDWARE REMOVAL, BILATERAL L3 LAMINECTOMIES AND LEFT L3-4 FACETECTOMY, L3-4 FUSION WITH TRANSVERSE POLY ETHYL-ETHYL KETONE CAGE, BILATERAL L3-4 PEDICLE SCREW INSTRUMENTATION AND BILATERAL PARASPINAL FUSION WITH CANCELLOUS BONE ALLOGRAFT AND AUTOGRAFT. THE PROCEDURE WAS PERFORMED UTILIZING INTRAOPERATIVE EMG NUVASIVE MONITORING AND UNDER MICROSCOPE MAGNIFICATION. AS PER OP-NOTES, ¿THE ANNULUS FIBROSIS OF THE L3-4 DISC WAS IDENTIFIED AND MOBILIZED FROM THE SURROUNDING TISSUES. THE ANNUAL FIBROSIS OF THE DISC WAS INCISED WITH A #11 BLADE FOLLOWED BY RADICAL DISCECTOMY AT THE L3-4 LEVEL USING CURETTES AND PITUITARY FORCEPS. AN 8 MILLIMETER IN HEIGHT, TRANSVERSE POLY-ETHYL-ETHYL- KETONE CAGE WAS FILLED UP WITH A SPONGE WITH BONE MORPHOGENIC PROTEIN.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 371588 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M110602AAE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |