INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2013-01773
- Event Type
- Injury
- Date Received
- May 20, 2013
- Report Date
- April 4, 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
PRODUCTS FROM MULTIPLE MANUFACTURERS WERE USED 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. IMPLANTED: 2006. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES OR MEDICAL RECORDS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
(B)(4).
(B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT ALLEGEDLY SUSTAINED UNSPECIFIED INJURIES RESULTING FROM A SPINAL FUSION SURGERY USING RHBMP-2/ACS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
IT WAS REPORTED THAT ON: (B)(6) 2006: THE PATIENT PRESENTED WITH A COMPLAINT OF SEVERE PAIN IN BACK THAT GOES DOWN INTO BOTH LEGS. ON (B)(6) 2006: THE PATIENT UNDERWENT CT GUIDED FACET BLOCKS DUE TO OSTEOARTHRITIS. IMPRESSION: SEVERE DEGENERATIVE CHANGES INVOLVE THE FACET JOINTS BILATERALLY; MORE SO ON THE RIGHT SIDE WHERE A POSTERIOR SYNOVIAL CYST IS PRESENT. THE NEEDLE TIP WAS AIMED AND ENTERED THE SYNOVIAL CYST AREA AND ASPIRATED. MODERATE DEGENERATIVE CHANGES INVOLVE THE DISTAL LUMBAR SPINE WITH PROMINENT NARROWING AT THE L5-S 1 INTERVERTEBRAL LEVEL. ON (B)(6) 2006: THE PATIENT PRESENTED WITH THE COMPLAINT OF FACET BLOCK ALLEVIATING ABOUT 60-70% OF PAIN. ON (B)(6) 2006: THE PATIENT UNDERWENT CT GUIDED FACET BLOCKS DUE TO OSTEOARTHRITIS. FINDINGS: PROMINENT DEGENERATIVE CHANGES INVOLVE THE FACET JOINTS BILATERALLY WITH A PROMINENT SYNOVIAL CYST INVOLVING THE DORSAL ASPECT OF THE RIGHT FACET JOINT. MODERATE NARROWING IS SEEN AT THE L4-5 INTERVERTEBRAL LEVEL WITH PROMINENT NARROWING AT THE L5-S 1 INTERVERTEBRAL LEVEL. ON (B)(6) 2006: THE PATIENT PRESENTED FOR FOLLOW UP VISIT FOR LOW BACK PAIN. ON (B)(6) 2006: THE PATIENT UNDERWENT CT SCAN OF LUMBAR SPINE WITH FIVE VIEWS DUE TO LOW BACK PAIN WITH NUMBNESS AND TINGLING. IMPRESSIONS: THERE WAS A DEXTROSCOLIOSIS OF THE UPPER LUMBAR SPINE. THERE WAS DISC NARROWING AT L5-S1. THERE IS SLIGHT RETROLISTHESIS OF L5 ON S1. THERE WAS MINIMAL SPONDYLOSIS OF L4 OVER L5 WHICH INCREASES SLIGHTLY WITH FLEXION. THERE WAS NO CHANGE IN NEUTRAL POSITION WITH EXTENSION. THERE WAS MARKED DEGENERATIVE CHANGE OF L1, T12 AND T11. THERE WAS A APPEARANCE OF FACET JOINT DEGENERATIVE CHANGE OF THE LUMBAR SPINE BILATERALLY. PATIENT ALSO UNDERWENT ELECTRODIAGNOSTIC STUDY. IMPRESSION: THE NEUROPATHY IS AXONAL IN NATURE AND AFFECTS THE MOTOR FIBERS OF THE RIGHT AND LEFT PERONEAL NERVE AND TIBIAL NERVE AS EVIDENCED ON THE NCV AND EMG STUDY. IT APPEARED THAT THE L5 AND S1 NERVE ROOT IS SLIGHTLY MORE AFFECTED ON THE LEFT SIDE THAN THE RIGHT SIDE. ON (B)(6) 2006: THE PATIENT PRESENTED FOR FRONTAL AND LATERAL VIEWS OF CHEST. IMPRESSION: POSTOPERATIVE AND BONY DEGENERATIVE CHANGES. NO EVIDENCE OF ACTIVE OR ACUTE PULMONARY DISEASE. ON (B)(6) 2006: THE PATIENT PRESENTED FOR CT OF LUMBAR SPINE DUE TO DEGENERATIVE LUMBAR DISC. IMPRESSIONS: THERE IS METALLIC STREAK ARTIFACT FROM LEFT TRANSPEDICULAR SCREW AND ROD FIXATION AT L4 THROUGH L5 LEVELS. THERE IS GROSSLY ANATOMIC ALIGNMENT OF THE LUMBAR SPINE. THE PATIENT ALSO UNDERWENT CT OF THORACIC AND LUMBAR SPINE. IMPRESSIONS: POSTOPERATIVE CHANGES OF THE THORACIC SPINE. FINDINGS SUSPICIOUS FOR A PATHOLOGIC FRACTURE OF T10 WITH EXTENSIVE PARAVERTEBRAL SOFT TISSUE DENSITY APPEARING TO EXTEND INTO THE CENTRAL CANAL WHERE THERE IS LIKELY CORD COMPRESSION. MOTTLED LUCENCY ALSO EXTENDING TO THE ADJACENT VERTEBRAL BODIES. ON (B)(6) 2006: THE PATIENT PRESENTED WITH A DIAGNOSIS OF L4-L5 DISC HERNIATION AND L4-S1 DEGENERATIVE DISC DISEASE. HENCE, THE PATIENT UNDERWENT L4-5 DISCECTOMY AS A DISTINCT PROCEDURE. AS PER OP-NOTES¿ INITIALLY A LAMINECTOMY AT THE INFERIOR ASPECT OF THE LEFT LAMINA OF L5 AND SAVED THE BONE DUST. THE LIGAMENTUM FLAVUM WAS INCISED WITH A 315 BLADE KNIFE AND THE THECAL SAC AND DESCENDING S1 ROOT AND EXITING L5 ROOTS WERE IDENTIFIED AND PROTECTED WITH A NERVE ROOT RETRACTOR. THEN A STANDARD DISCECTOMY USING VARIOUS SIZE CURETS, PITUITARY RONGEURS AND SHAVERS WAS DONE. A SPACER WAS USED AND A 10 X 26 MM GRAFT WAS FILLED WITH AUTOLOGOUS BONE AND BMP . A SEPARATE BURRITO OF BMP AND AUTOLOGOUS BONE WAS PLACED INTO THE DISC SPACE ANTERIORLY. THIS WAS FOLLOWED BY CAPSTONE GRAFT UNDER FLUOROSCOPIC GUIDANCE TO THE MIDLINE AND TOWARD THE ANTERIOR EDGES OF THE VERTEBRAL BODY. A SIMILAR PROCEDURE WAS CARRIED OUT AT L4-L5 BUT FIRST A DISCECTOMY FOR A SUBLIGAMENTOUS DISC HERNIATION WAS PERFORMED. A 12 X 26 MM GRAFT WAS USED HERE. ONCE THIS WAS DONE, 6.5 X 40 MM SCREWS INTO L4, L5 AND 7.5 X 30 MM SCREWS INTO S1 WERE PLACED. CONNECTING RODS AND BROKE OFF SET SCREWS WERE PUT WITH THE ATTACHED TORQUE WRENCH PUTTING THE INTERBODY GRAFTS INTO COMPRESSION. THEN LAMINA ON THE RIGHT SIDE OF L4-L5 AND S1 WITH THE MIDAS REX DRILL WAS DECORTICATED AND PLACED FURTHER BURRITOS OF BMP AND AUTOLOGOUS BONE OVER DECORTICATED REGIONS. FINALLY, A 45 MM SPIRE PLATE WAS APPLIED FROM THE SPINOUS PROCESS OF L4 TO L5 TO S1 IN THE MIDLINE. THERE WERE NO COMPLICATIONS FROM THE PROCEDURE AND THE PATIENT TOLERATED THE PROCEDURE WELL.¿ ON (B)(6) 2006: THE PATIENT UNDERWENT CT SCAN OF HEAD DUE TO HEMATOMA. IMPRESSION: PARTIAL CLEARING OF PREVIOUSLY NOTED SUBDURAL HEMATOMA. PERSISTENT DENSITY OVER THE TENTORIUM AND IN THE VENTRICLES CONSISTENT WITH SOME SUBARACHNOID BLOOD. FINDINGS SUGGESTIVE OF BASAL SKULL FRACTURE. ON (B)(6) 2006: THE PATIENT PRESENTED FOR X-RAY OF LUMBAR SPINE DUE TO BACK PAIN. IMPRESSION: SEVERE DEGENERATIVE CHANGES, OSTEOPENIA. COMPRESSION DEFORMITY FOR T11 OF UNCERTAIN CHRONICITY. COMPRESSION DEFORMITY FOR L2. ON (B)(6) 2006: THE PATIENT PRESENTED FOR FOLLOW UP ON HYPERLIPIDEMIA. THE PATIENT ALSO HAD A SHARP AND BURNING SENSATION OCCASIONALLY IN THE LEFT LATERAL THIGH AREA AND IN THE DORSUM OF RIGHT HAND, HAD THREE EPISODES OF MARKED ANXIETY RELATED TO CLAUSTROPHOBIA AND COMPLAINTS OF ERECTILE DISCOMFORT DYSFUNCTION. ON (B)(6) 2006: THE PATIENT PRESENTED WITH A COMPLAINT OF A NUMB FEELING IN THE OUTER PORTION IN THE LEFT EAR CANAL. ON (B)(6) 2006: THE PATIENT PRESENTED FOR FOLLOW UP FOR BACK PAIN AND ALSO HAD PULLING SENSATION IN BACK. ON (B)(6) 2006: THE PATIENT PRESENTED LUMBAR SPINE VIEW. OPINION: NO SUBLUXATION. EXTENSIVE CHRONIC CHANGE. ON (B)(6) 2006: THE PATIENT PRESENTED FOR FOLLOW UP VISITS DUE TO BACK PAIN. ON (B)(6) 2006: THE PATIENT PRESENTED FOR LATERAL VIEW OF LUMBAR SPINE. FINDINGS: THERE HAS BEEN POSTERIOR FUSION AT L4-L5 AND L5-S1. THERE WAS NO SUBLUXATION. BONE DENSITY INCREASED AT T12-L1, MOST LIKELY DUE TO EXTENSIVE OSTEOPHYTE FORMATION. THERE WAS STABLE LOSS OF HEIGHT OF T11 AND T12 AS WELL. ON (B)(6) 2006, (B)(6) 2007: THE PATIENT PRESENTED FOR FOLLOW UP VISITS DUE TO BACK PAIN. ON (B)(6) 2007: THE PATIENT PRESENTED FOR MRI DUE TO LOW BACK PAIN. IMPRESSION: NO RECURRENT DISC HERNIATION IS IDENTIFIED. NO SPINAL STENOSIS WAS SEEN. NO BONY METASTASIS OF THE LUMBAR SPINE IS IDENTIFIED. PATIENT PROMINENT LATERAL BULGING OF THE L4-L5 DISC INTO THE INFERIOR ASPECT OF THE NEURAL FORAMINA AND LATERALLY ON THE RIGHT AT L4-L5. NO DISC HERNIATION OR SPINAL STENOSIS WAS IDENTIFIED. SEVERE DISC SPACE NARROWING AND DISC DEGENERATION WAS SEEN AT T12-L1. MODERATE DISC SPACE NARROWING WAS SEEN AT L4-L5. THERE WAS MILD FOCAL CENTRAL BULGING OF THE L4-L5 AND L5-S1 DISCS. ON (B)(6) 2007: THE PATIENT PRESENTED FOR FOLLOW UP OF LOW BACK PAIN. THE PATIENT STATED THAT PAIN GOES ONLY TO THE BUTTOCK. THE PATIENT ALSO HAD MRI WHICH DID NOT SHOW ANY SIGNIFICANT DISK HERNIATION OR STENOSIS. ON (B)(6) 2007: THE PATIENT PRESENTED FOR FOLLOW UP OF LOW BACK PAIN. ON (B)(6) 2007: THE PATIENT PRESENTED WITH CONGESTION, COUGH AND POSTNASAL DRAINAGE WITH A WHEEZING NOISE, ESPECIALLY WHILE LYING DOWN. ON (B)(6) 2007: THE PATIENT PRESENTED FOR FOLLOW UP VISIT DUE TO HYPERTENSION AND LIPIDS. ON (B)(6) 2007: THE PATIENT PRESENTED FOR COLONOSCOPY PROCEDURE. NO IMMEDIATE COMPLICATIONS. THE PATIENT TOLERATED THE PROCEDURE WELL. IMPRESSION: NON-THROMBOSED INTERNAL HEMORRHOIDS. PROLAPSED HEMORRHOIDS WITH SPONTANEOUS REDUCTION. DIVERTICULOSIS. ON (B)(6) 2012: THE PATIENT PRESENTED WITH A COMPLAINT OF BACK PAIN. THE PAIN WAS DESCRIBED AT BEING LOCATED IN THE LOW BACK AND RADIATING TO THE RIGHT LOWER EXTREMITY AND LEFT LOWER EXTREMITY. THE PAIN WAS REPORTED TO BE WORSE WITH STANDING. ON (B)(6) 2007, (B)(6) 2008: THE PATIENT PRESENTED FOR FOLLOW UP FOR MEDICATIONS. ON (B)(6) 2008: THE PATIENT PRESENTED WITH CONGESTION, COUGH WITH A WHEEZING NOISE. ON (B)(6) 2009: THE PATIENT PRESENTED WITH SOME ACHING IN LEFT SHOULDER. ON (B)(6) 2009: THE PATIENT PRESENTED WITH LEFT HAND PAIN AND NUMBING PAIN IN LEFT FOOT AND IS GETTING WORST. ON (B)(6) 2010: THE PATIENT PRESENTED WITH A COMPLAINT OF WHEEZING, NASAL CONGESTION, VOICE LOSS MILD AND COUGHS. ON (B)(6) 2010: THE PATIENT PRESENTED FOR DISCUSSION OF MEDICATIONS. ON (B)(6) 2010: THE PATIENT PRESENTED FOR FOLLOW UP ON ¿TENS¿ UNIT. ON (B)(6) 2010, (B)(6) 2011: THE PATIENT PRESENTED FOR FOLLOW UP ON USUAL MEDICAL PROBLEMS. PATIENT CONTINUED TO HAVE LOW BACK PAIN AND HAD TO STOP WALKING FREQUENTLY TO RELIEVE THIS. ON (B)(6) 2011: THE PATIENT PRESENTED WITH PERSISTENT SORENESS BETWEEN HIS UPPER AND LOWER GUMS INSIDE HIS MOUTH, PAIN AND MILD CRACKING WHEN TRYING TO RETRACT HIS FORESKIN, INCREASED NUMBNESS IN THE LEFT FOOT AND NUMBNESS IN LEFT THIGH. THE PATIENT EXPERIENCES COLDNESS AT ENDS OF THE FINGERS. PHYSICAL EXAMINATION INDICATED THAT A LARGE ULCER WAS PRESENT AT THE ANGLE BETWEEN THE UPPER AND LOWER ALVEOLAR RIDGES ON THE LEFT SIDE AND FORESKIN APPEARED SLIGHTLY IRRITATED. ON (B)(6) 2011: THE PATIENT PRESENTED FOR FOLLOW UP VISIT DUE TO LEFT KNEE PAIN AND MEDICATIONS. ON (B)(6) 2011: THE PATIENT PRESENTED FOR PREOPERATIVE PHYSICAL EXAM PRIOR TO LEFT KNEE SURGERY. ON (B)(6) 2012: THE PATIENT PRESENTED WITH A PROBLEM OF REFLUX OCCURRING WHILE LYING IN BED AT NIGHT. ON (B)(6) 2012: THE PATIENT PRESENTED WITH PAIN IN THE RIGHT LEG WITH NO INJURY OR INCIDENT. THE PATIENT HAD CHRONIC PAIN IN THE LEFT LEG WITH SOME NUMBNESS LATERALLY. PATIENT ALSO HAD PAIN IN THE BUTTOCK AND HIP AREA ON THE RIGHT TO THE ANTEROLATERAL THIGH. PATIENT ALSO HAD PAIN IN LOWER BACK WITH PRESSURE ON THE BACK. THERE WAS A FUSION WITH PEDICLE SCREWS AND X-STOP. THERE IS PSEUDOARTHROSIS OF THE L5-S1 LEVEL WITH GAS IN THE DISC SPACE AROUND THE CAGE. THERE IS MULTIPLE LEVEL FACET JOINT DEGENERATION AND GAS IN THE DISC SPACE OF THE LUMBAR SPINE EXCEPT L4-L5. THE PEDICLE SCREWS ARE LOCATED ON THE LEFT SIDE ONLY. THERE IS SIGNIFICANT ENDPLATE CHANGE NOTED ON THE L5-S1 AND T12. THE PATIENT ALSO UNDERWENT CT OF LUMBAR SPINE. IMPRESSIONS: THERE IS MULTILEVEL DEGENERATIVE DISC DISEASE WITH PRIOR KEYHOLE LAMINECTOMY ON THE RIGHT AT L4-L5 AND L5-S1. POSTERIOR STABILIZATION IS SEEN. THERE IS SOME SUGGESTION OF SOME RIGHT SIDED NEURAL FORAMINAL NARROWING AT L3-L4 AND L4-L5, PARTICULARLY ON THE RIGHT. SCLEROTIC CHANGES ARE SEEN INVOLVING SEVERAL VERTEBRAL LEVELS WHICH ARE PROBABLY RELATED TO DEGENERATIVE DISC DISEASE. NON-DISPLACED FRACTURE INVOLVING THE PARS INTERARTICULARIS LEFT L5 LEVEL. ON (B)(6) 2012: THE PATIENT PRESENTED FOR FOLLOW UP FOR CHRONIC LUMBAR PAIN. ON (B)(6) 2012: THE PATIENT PRESENTED FOR FOLLOW UP FOR BACK PAIN. PATIENT ALSO STATED THAT SOME NUMBNESS IN THE LEFT LEG TO THE FOOT ALSO OCCURS. ON (B)(6) 2012: THE PATIENT PRESENTED FOR NUCLEAR MEDICINE BONE SCAN DUE TO LEFT KNEE PAIN. IMPRESSION: MODERATELY INCREASED ACTIVITY AROUND THE TIBIAL COMPONENT OF THE PROSTHESIS AND IN THE PATELLOFEMORAL AREA. LOOSENING AND INFECTION CANNOT BE EXCLUDED. ON (B)(6) 2012: THE PATIENT PRESENTED FOR FOLLOW UP VISIT FOR BACK PAIN. ON (B)(6) 2012: THE PATIENT WAS DIAGNOSED WITH LUMBAR DEGENERATIVE DISC, CHRONIC PAIN SYNDROME AND NEURALGIA/NEURITIS. HENCE, PATIENT UNDERWENT PERCUTANEOUS IMPLANT NEUROSTIMULATOR, FLUOROSCOPIC GUIDANCE FOR SPINE INJECTION, IMPLANTABLE NEURO ELECTRODES AND COMPLEX PROGRAMMING. ON (B)(6) 2012: THE PATIENT PRESENTED WITH FOLLOW UP VISIT DUE TO CONTINUED BACK PAIN. ON (B)(6) 2012: THE PATIENT PRESENTED FOR DIAGNOSIS OF CHEST VIEW. IMPRESSION: NO ACUTE FINDINGS. ON (B)(6) 2012: THE PATIENT PRESENTED WITH A FOLLOW UP VISIT FOR UPSET STOMACH AND INDIGESTION. ON (B)(6) 2012: THE PATIENT PRESENTED FOR X-RAY LUMBAR SPINE DUE TO HISTORY OF LOW BACK PAIN. IMPRESSIONS: POSTOPERATIVE CHANGES AT L4-S1 WITHOUT EVIDENCE FOR COMPLICATION. SEVERE DEGENERATIVE DISC DISEASE AT T11-12 AND T12-L1. NO EVIDENCE FOR INSTABILITY. ON (B)(6) 2012: THE PATIENT PRESENTED FOR FOLLOW UP VISIT FOR MEDICATIONS. ON (B)(6) 2013: THE PATIENT PRESENTED FOR FLUORO ESOPHAGRAM DUE TO DYSPHAGIA, SHORTNESS OF BREATH AFTER SWALLOWING. THE PATIENT STATUS POST FUSION OF THE MID CERVICAL SPINE WITH A COMPRESSION PLATE NOTED ANTERIORLY. THE CERVICAL AND THORACIC ESOPHAGUS APPEARS NORMAL. THERE IS NO MASS, MUCOSAL ABNORMALITY, STRUCTURE OR SIGNIFICANT HIATAL HERNIA EVIDENT. NO ACUTE FINDINGS. ON (B)(6) 2013: THE PATIENT PRESENTED WITH A PROBLEM OF COUGH AND CONGESTION. ON (B)(6) 2013: THE PATIENT PRESENTED FOR CT CERVICAL SPINE WITHOUT CONTRAST DUE TO RADICULAR PAIN. IMPRESSIONS: NO EVIDENCE FOR CERVICAL SPINE FRACTURE. DEGENERATIVE CHANGES AT C4-C5 AND C5-C6 WITHOUT ANY SIGNIFICANT CANAL STENOSIS. THE PATIENT PRESENTED FOR CT THORACIC SPINE WITHOUT CONTRAST DUE TO RADICULAR PAIN. IMPRESSIONS: NO FRACTURES. SEVERE DEGENERATIVE DISC DISEASE AT T12-L1 WITH A POSTERIOR DISC OSTEOPHYTE COMPLEX CAUSING MODERATE LEFT NEURAL FORAMINAL STENOSIS. ON (B)(6) 2013: THE PATIENT PRESENTED FOR X-RAY OF SHOULDER DUE TO PAIN. IMPRESSIONS: AC DISSOCIATION. SOFT TISSUE CALCIFICATION ADJACENT TO THE GREATER TUBEROSITY MOST SUGGESTIVE OF CALCIFIC TENDINOPATHY. ON (B)(6) 2013: THE PATIENT PRESENTED FOR X-RAY OF CHEST DUE TO PAIN. IMPRESSION: NORMAL PORTABLE CHEST RADIOGRAPH. THE PATIENT ALSO UNDERWENT CT ANGIO CHEST FOR PULMONARY EMBOLUS DUE TO CHEST PAIN AND TACHYCARDIA. FINDINGS: THERE IS NO EVIDENCE OF PULMONARY EMBOLISM. LUNGS ARE ESSENTIALLY CLEAR. THERE IS NO PNEUMONIA, CONGESTIVE HEART FAILURE OR EFFUSIONS. NO ENLARGED MEDIASTINAL LYMPH NODES. THERE IS MODERATE TO SEVERE CORONARY ARTERY CALCIFICATIONS. A FEW IMAGES BELOW THE DIAPHRAGM INCIDENTALLY DEMONSTRATE A HETEROGENEOUS LESION IN THE REGION OF THE RIGHT ADRENAL GLAND. THERE ARE THREE TO FOUR FATTY DENSITY FOCI WITHIN IT. THIS MAY REPRESENT A BENIGN PROCESS SUCH AS ADENOMA OR ANGIOMYOLIPOMA. ON (B)(6) 2013: THE PATIENT PRESENTED FOR MYOCARDIAL PERFUSION SCAN DUE TO ATYPICAL CHEST PAIN. IMPRESSION: NORMAL MYOCARDIAL PERFUSION. NORMAL LEFT VENTRICULAR WALL MOTION WITH A 62% EJECTION FRACTION. ON (B)(6) 2013: THE PATIENT PRESENTED WITH A CHIEF COMPLAINT OR RIGHT SHOULDER PAIN. PATIENT STATED PAIN FROM SHOULDER RADIATES DOWN THE ARM. ON (B)(6) 2013: THE PATIENT PRESENTED WITH ELECTRIC SENSATIONS IN THE NECK. PATIENT WAS DIAGNOSED WITH CERVICAL STENOSIS, CERVICAL DISC DISPLACEMENT WITH MYELOPATHY AND CERVICAL SPONDYLOSIS WITH MYELOPATHY. THE PATIENT PRESENTED FOR X-RAY OF CERVICAL SPINE WITH FLEXION AND EXTENSION DUE TO PAIN. FINDINGS: NO EVIDENCE OF AN ACUTE COMPRESSION FRACTURE. THE PATIENT IS STATUS POST ANTERIOR FUSION AT THE LEVEL OF C3-C4 WITH A COMPRESSION PLATE NOTED ANCHORED AT THIS LEVEL. THE FLEXION AND EXTENSION VIEWS SHOW NO EVIDENCE OF INSTABILITY. THERE ARE DEGENERATIVE CHANGES WITH NARROWING OF THE INTERVERTEBRAL DISC SPACE. AT THE LEVEL OF C4-C5 AND C5-C6 WITH NEAR COMPLETE OBLITERATION OF THE DISC SPACE AND ENDPLATE SCLEROSIS. IN THE OBLIQUE VIEWS, THERE IS ENCROACHMENT OF THE NEURAL FORAMINA AT THE LEVEL OF C4-C5 AND C5-C6. IMPRESSIONS: MULTILEVEL DEGENERATIVE CHANGES. GOOD POSTOPERATIVE ALIGNMENT OF THE CERVICAL SPINE. NO RADIOGRAPHIC EVIDENCE OF INSTABILITY. ON (B)(6) 2013: THE PATIENT PRESENTED FOR FOLLOW UP VISIT DUE TO SEVERE NECK PAIN AND ARM AND LEG WEAKNESS. THE PATIENT HAD DISC HERNIATION AT C6-C7 WITH SUPERIORLY MIGRATING FREE FRAGMENT ALONG WITH SEVERE STENOSIS AT C6-C7 WITH COMPRESSION OF THE SPINAL CORD. ON (B)(6) 2013: THE PATIENT PRESENTED FOR X-RAY CHEST PA <(>&<)> LATERAL FOR PRE-OP FOR SPINAL SURGERY. FINDINGS: CARDIAC SIZE IS WITHIN NORMAL LIMITS. THERE ARE NO INFILTRATES, EDEMA, OR PLEURAL EFFUSIONS. NO ACUTE RADIOGRAPHIC FINDINGS. ON (B)(6) 2013: THE PATIENT PRESENTED FOR PRE-OP PHYSICAL FOR CERVICAL SPINE SURGERY. ON (B)(6) 2013: THE PATIENT PRESENTED WITH INABILITY TO LIFT LEGS OFF THE BED AND MORE DIFFICULTY IN MOVING ARMS. THE PATIENT WAS DIAGNOSED WITH C4-C7 STENOSIS. HENCE, PATIENT UNDERWENT C4-C7 DE-COMPRESSIVE LAMINECTOMY WITH PARTIAL MEDIAL FACETECTOMY, DECOMPRESSION OF THE LATERAL RECESSES AND FORAMINOTOMIES. LATERAL ARTHRODESIS WITH AUTOGRAFT AND ALLOGRAFT . THERE WERE NO COMPLICATIONS FROM THIS PROCEDURE AND THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT UNDERWENT X-RAY OF LUMBAR SPINE. IMPRESSIONS: ACDF NOTED AT THE C3-C4 LEVEL. THE MARKER WAS NOTED POSTERIOR TO THE LOWER SCREWS AT THE ACDF WHICH WAS LIKELY THE C4 LEVEL. ON (B)(6) 2013: THE PATIENT PRESENTED FOR X-RAY OF CHEST. IMPRESSION: SMALL LEFT-SIDED PLEURAL EFFUSION/ATELECTASIS. ON (B)(6) 2013: THE PATIENT PRESENTED FOR FOLLOW UP VISIT DUE TO MILD ACHE ALONG THE RIGHT HIP AREA. ON (B)(6) 2013: THE PATIENT PRESENTED FOR X-RAY CERVICAL SPINE FOR FOLLOW UP DUE TO FUSION OF CERVICAL SPINE AT C3-C4. FINDINGS: THIS IS A VERY LIMITED SET OF RADIOGRAPHS. THERE IS EVIDENCE OF FUSION OF C3-C4. HOWEVER, THE FUSION APPEARS ADEQUATE. HOWEVER, THE C5 AND C6 VERTEBRAL BODIES APPEAR TO SHOW SIGNIFICANT DEGENERATIVE CHANGES THAT APPEAR MORE PRONOUNCED. ALSO, THE SPINOUS PROCESS OF C5 AND C6 ARE NOT VISUALIZED AND THIS MAY BE POST SURGICAL CHANGE OR AN EROSIVE PROCESS IF THERE IS NO RECENT SURGERY IN THAT REGION. THERE IS INCREASING LORDOSIS AT THE C5-C6. ON (B)(6) 2013: THE PATIENT PRESENTED FOR FOLLOW UP VISIT WITH MINIMAL BACK PAIN. ON (B)(6) 2013: THE PATIENT PRESENTED WITH A CHIEF CONCERN ON SHINGLES. HOWEVER THE MAIN SYMPTOM WAS ITCHING ON THE LATERAL CHEST WALL BOTH SIDES. ON (B)(6) 2013: THE PATIENT PRESENTED FOR FOLLOW UP ON MEDICATIONS. ON (B)(6) 2014: THE PATIENT PRESENTED FOR US ARTERIAL DOPPLER LOWER EXTREMITY BILATERAL FROM BIFURCATION DUE TO BILATERAL CLAUDICATION, LEG PAIN AND NUMBNESS. FINDINGS: TRIPHASIC WAVEFORMS WITH NORMAL VELOCITIES WAS SEEN IN BILATERAL COMMON ILIAC ARTERIES. EXTERNAL ILIAC ARTERIES, COMMON FEMORAL ARTERIES, SFA, POPLITEAL, DORSALS PEDIS AND POSTERIOR TIBIAL ARTERIES. ON (B)(6) 2014: THE PATIENT PRESENTED FOR FOLLOW UP ON USUAL MEDICAL PROBLEMS. ON (B)(6) 2014: THE PATIENT PRESENTED WITH A CHIEF COMPLAINT ON INJECTION SITE REDNESS ON LOWER BACK FROM PROCEDURE. ON (B)(6) 2014: THE PATIENT PRESENTED FOR BP ISSUES. ON (B)(6) 2014: THE PATIENT PRESENTED FOR FLUOROSCOPIC GUIDED LUMBAR MYELOGRAM. IMPRESSION: SUCCESSFUL FLUOROSCOPIC ¿GUIDED LUMBAR MYELOGRAM DEMONSTRATING MULTI LEVEL DISC DISEASE AND AREAS OF STENOSIS. ON (B)(6) 2014: THE PATIENT PRESENTED FOR FOLLOW UP FOR USUAL MEDICAL PROBLEMS. THE PATIENT CONTINUED TO HAVE MARKED BACK PAIN DUE TO OSTEOARTHRITIS. ON (B)(6) 2014: THE PATIENT UNDERWENT X-RAY OF CHEST DUE TO PRODUCTIVE COUGH. IMPRESSION: RIGHT UPPER LOBE NODULE AND SUBTLE LEFT LOWER LOBE INFILTRATE. ON (B)(6) 2015: THE PATIENT PRESENTED WITH SWELLING IN LOWER EXTREMITIES AND X-RAY AT HOSPITAL SHOWED SPOT ON LUNG AND KIDNEY. ON (B)(6) 2015: THE PATIENT PRESENTED FOR CT OF CHEST WITH FOUR CONTRASTS. IMPRESSION: 1.4 X 1.6 CM LOBULATED NODULE IN THE RIGHT UPPER LOBE. THIS IS MODERATELY CONCERNING FOR MALIGNANCY. ON (B)(6) 2015: THE PATIENT UNDERWENT PET CT DUE TO SOLITARY PULMONARY NODULE, NEOPLASM OF UNCERTAIN BEHAVIOR OF TRACHEA, BRONCHUS AND LUNGS. IMPRESSION: HYPERMETABOLIC 1.5 CM RIGHT UPPER LOBES NODULE IS SUSPICIOUS FOR A PRIMARY LUNG CARCINOMA. NO EVIDENCE FOR METASTATIC LYMPHADENOPATHY TO THE CHEST. THERE IS A HYPERMETABOLIC LESION IN THE RIGHT ADRENAL GLAND AND DOES APPEAR TO HAVE A FATTY ELEMENT CONSISTENT WITH A MYELOLIPOMA.
IT WAS REPORTED THAT ON (B)(6) 2006, THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AND LATERAL FUSION SURGERY FROM VERTEBRAE L4 TO S1. HE WAS IMPLANTED WITH RHBMP-2/ACS. POST-SURGERY, HE EXPERIENCED PROGRESSIVELY WORSENING PAIN IN HIS LOW BACK AND BUTTOCKS, WITH ASSOCIATED PAIN AND RADICULOPATHY IN HIS LOWER EXTREMITIES. CURRENTLY, THE PATIENT CONTINUES TO EXPERIENCE SEVERE AND CHRONIC LOWER BACK AND HIP PAIN, RADIATING PAIN AND PINS AND NEEDLES DOWN HIS RIGHT LEG TO HIS KNEE, AND SWELLING IN HIS CALVES AND FEET. HE CANNOT STAND OR WALK FOR ANY PERIOD OF TIME. HE WAS UNABLE TO ENJOY HIS DAILY ACTIVITIES THAT HE ENJOYED PREOPERATIVELY, AND HAD SUFFERED SERIOUS AND PERMANENT INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222262 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M115006AAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |