INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2013-01778
- Event Type
- Injury
- Date Received
- May 21, 2013
- Report Date
- August 30, 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)(6). (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)(4).
(B)(4).
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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) 2011: THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: PSEUDOARTHROSIS L5-S1. SHE HAD THE FOLLOWING POST-OP DIAGNOSIS: PSEUDOARTHROSIS L4-L5, L5-S1. SHE UNDERWENT THE FOLLOWING PROCEDURES: BILATERAL LAMINECTOMY, L4-5, L5-S1; PEDICLE SCREWS AT L4, L5, S1; POSTEROLATERAL FUSION, L4-5, S1. PATHOLOGICAL FINDINGS: THERE IS SOME MILD TO MODERATE SPINAL STENOSIS WITH SOME ENLARGED FACETS. PER-OP NOTES: DECOMPRESSION WAS DONE AT L4-5 AND L5-S1. SCREWS WERE PLACED IN THE NECK, A ROD WAS PLACED AND DISTRACTED AT L4-5 AND THERE WAS SHOULDER MOVEMENT AT L5-S1 ALSO. SURGEON THEN ROUGHENED UP THE POSTEROLATERAL BONE AND PLACED MORSELIZED AUTOGRAFT AND BMP WAS PLACED OVER THAT. NUTS WERE TIGHTENED ON THE RODS AND BROKEN OFF. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT UNDERWENT DIAGNOSIS OF LUMBAR SPINE 2 OR 3 VIEWS. IMPRESSION: ANTERIOR AND POSTERIOR FUSION EXTENDING FROM L4 TO S1; HARDWARE APPEARS INTACT. PATIENT ALSO UNDERWENT PORTABLE FLUOROSCOPY. IMPRESSION: POTABLE FLUOROSCOPY UTILIZED FOR 30 SECONDS. ON (B)(6) 2011: PATIENT PRESENTED FOR OFFICE VISIT WITH LOW BACK PAIN. ON (B)(6) 2011: PATIENT UNDERWENT LUMBAR SPINE 3 VIEWS. IMPRESSION: SCREWS IN THE PEDICLE AND BODIES OF L4-5 AND THE BASE OF SACRUM, AND ATTACHED TO THE METALLIC RODS POSTERIORLY. ALIGNMENT APPEARS TO BE SATISFACTORY. ON (B)(6) 2011: PATIENT PRESENTED FOR OFFICE VISIT WITH LOW BACK PAIN. THERE IS NO LEG PAIN. ON (B)(6) 2011: PATIENT UNDERWENT LUMBAR SPINE 3 VIEWS. IMPRESSION: POST-OP CHANGES ARE THERE. NO CHANGE IN POSITION AND ALIGNMENT OF PLATE AND SCREW DEVICES. BONY FUSION IS NOT COMPLETE. NO OTHER ABNORMALITIES. NO EVIDENCE OF RECENT FRACTURE. ON (B)(6) 2011: PATIENT PRESENTED FOR OFFICE VISIT WITH LOW BACK PAIN. THERE IS NO LEG PAIN. PATIENT HAS PAIN LEANING FORWARDS AND BACKWARDS. PATIENT HAS LITTLE PAIN DOWN THE RIGHT LEG. ON (B)(6) 2012: PATIENT UNDERWENT LUMBAR SPINE 3 VIEWS. IMPRESSION: POSTOPERATIVE CHANGES ARE THERE. ANTERIORLY PLATE AND SCREW DEVICES ARE SEEN IN PLACE AT L4-L5 AND L5-S1. MINIMAL DEGENERATIVE CHANGES AT L3 AND MINIMAL SCOLIOSIS WITH CONVEXITY PRESENT TO THE LEFT IN THE LUMBAR SPINE. NO NEW ABNORMALITIES. ON (B)(6) 2012: PATIENT PRESENTED FOR OFFICE VISIT WITH LOW BACK PAIN. PATIENT SOMETIMES GETS A LITTLE PAIN INTO THE LEGS. ON (B)(6) 2013: PATIENT UNDERWENT MRI LUMBAR SPINE WITH/WITHOUT CONTRAST. IMPRESSION: STABLE ANTERIOR INTERBODY POSTERIOR FUSION L4-L5 AND L5-S1. POST CONTRAST IMAGING DEMONSTRATES SCAR FORMATION SURROUNDING THE THECAL SAC AND THE L5-S1 NERVE ROOTS AS THEY EXIT THE THECAL SAC AT L4-L5 AND L5-S1 LEVELS. NO EVIDENCE OF NEW DISC HERNIATION OR ADDITIONAL FOCAL AREAS OF NERVE ROOT IMPINGEMENT. PATIENT UNDERWENT X-RAY LUMBAR SPINE 2 VIEWS WITH FLEXIONS AND EXTENSIONS. IMPRESSION: STABLE ANTERIOR POST FUSION L4 THROUGH S1 WITH NO INSTABILITY DURING FLEXION AND EXTENSIVE VIEWS. PATIENT ALSO UNDERWENT X-RAY LUMBAR SPINE 3 VIEWS. IMPRESSION: ANTERIOR/POSTERIOR FUSION L4 THROUGH S1. NO INSTABILITY OR POSTOP COMPLICATIONS DEMONSTRATED. PATIENT ALSO UNDERWENT X-RAY CERVICAL SPINE WITH FLEXIONS AND EXTENSIONS. IMPRESSION: STABLE ANTERIOR INTERBODY FUSION C3 THROUGH C6 WITHOUT INSTABILITY ON FLEXION OR EXTENSION VIEWS. PATIENT ALSO UNDERWENT 3 VIEWS OF THE CERVICAL SPINE. IMPRESSION: STABLE ANTERIOR INTERBODY FUSION C3-C6. PATIENT ALSO UNDERWENT MR CERVICAL SPINE WITHOUT CONTRAST. IMPRESSION: STABLE ANTERIOR INTERBODY FUSION C3-C6 WITH NO EVIDENCE OF RECURRENT DISC HERNIATION OR POSTERIOR OSTEOPHYTIC CHANGE. NO FOCAL NERVE ROOT IMPINGEMENT IS NOTED (B)(6) 2014: PATIENT UNDERWENT RIGHT SHOULDER 2 VIEWS. IMPRESSION: NO ACUTE BONY FINDING OF THE RIGHT SHOULDER. PATIENT ALSO UNDERWENT 1 TO 2 VIEWS OF PELVIS. IMPRESSION: NO ACUTE BONY FINDINGS OF THE PELVIS AND HIPS; POSTOP CHANGES OF LUMBOSACRAL SPINE AND SCLEROTIC CHANGES AT THE SI JOINTS, MOST SIGNIFICANT ON THE LEFT. SI JOINT CHANGES COULD REPRESENT DEGENERATIVE CHANGE AND SACROILITIS AGE IN DETERMINANT. PATIENT ALSO UNDERWENT CT CERVICAL SPINE WITHOUT CONTRAST. IMPRESSION: NO ACUTE BONY FINDING OF THE CERVICAL SPINE. POSTOP AND DEGENERATIVE CHANGES ARE THERE WITH MINIMAL ANTEROLISTHESIS OF C6 ON C7. PATIENT ALSO UNDERWENT CT BRAIN HEAD WITHOUT CONTRAST. IMPRESSION: NO CT EVIDENCE OF ACUTE INTRACRANIAL BLEED, INFARCT OR MASS. CHRONIC APPEARING PARANASAL SINUS DISEASE. ON (B)(6) 2014: PATIENT UNDERWENT MAMMOGRAPHY FOR CLINICAL INDICATION OF BREAST CANCER SCREENING. IMPRESSION: NO MAMMOGRAPHIC EVIDENCE OF MALIGNANCY IDENTIFIED.
IT WAS REPORTED THAT ON (B)(6) 2012: THE PATIENT UNDERWENT DIGITAL MAMMOGRAPHY BILATERALLY FOR ANNUAL EXAMINATION. IMPRESSION: NO MAMMOGRAPHIC EVIDENCE OF MALIGNANCY. ON (B)(6) 2013: PATIENT PRESENTED WITH CHIEF COMPLAINT OF LEFT WRIST PAIN. MUSCULOSKELETAL EXAMINATION REVEALS LEFT WRIST INFLAMMATION, TENDERNESS TO PALPATION, DECREASED RANGE OF MOTION DUE TO PAIN. ASSESSMENT: JOINT PAIN AND GOUT. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT DUE TO POSS GOUT. PATIENT COMPLAINS OF RIGHT ANKLE TENDERNESS. ASSOCIATED SYMPTOMS INCLUDE WARMTH TO TOUCH AND MILD INFLAMMATION. MUSCULOSKELETAL EXAMINATION IS POSITIVE FOR FOOT /ANKLE PAIN, RIGHT ANKLE TENDERNESS TO PALPATION, SLIGHTLY DECREASED ROM DUE TO TENDERNESS. RIGHT ANKLE ERYTHEMA AND MILD INFLAMMATION. ASSESSMENT: ACUTE GOUT. ON (B)(6) 2014: PATIENT PRESENTED FOR OFFICE VISIT DUE TO POSS UTI, GOUT AND MENOPAUSAL SYMPTOMS. PATIENT REPORTS DISCOMFORT WITH URINATION AND HAVING SOME LEFT WRIST MILD JOINT PAIN WITH WARMTH AND MILD SWELLING. MUSCULOSKELETAL EXAMINATION IS POSITIVE FOR JOINT PAIN, WARMTH AND SWELLING. ASSESSMENT : UTI, ACUTE GOUT, MENOPAUSAL SYMPTOMS. ON (B)(6) 2014: PATIENT PRESENTED FOR LAB TESTS. ASSESSMENTS: HYPERTENSION, HYPERLIPIDEMIA, GOUT. ON (B)(6) 2014: PATIENT PRESENTED FOR OFFICE VISIT DUE TO POSS UTI AND COMPLAINS OF LOW BACK PAIN. ASSESSMENT: ACUTE GOUT, UTI, SHORTNESS OF BREATH ON EXERTION. ON (B)(6) 2014: PATIENT PRESENTED FOR OFFICE VISIT AND COMPLAINS OF DIZZINESS. ASSESSMENT: OTITIS MEDIA AND DIZZINESS. ON (B)(6) 2014: PATIENT PRESENTED FOR OFFICE VISIT AND COMPLAINS OF DIZZINESS SIMILAR TO WHEN SHE HAD EAR INFECTION. ASSOCIATED SYMPTOMS INCLUDE FEVER/CHILLS, SORE THROAT AND SINUS CONGESTION. ASSESSMENT: SINUSITIS, SEROUS OTITIS MEDIA, DIZZINESS, PHARYNGITIS. ON (B)(6) 2014: PATIENT PRESENTED FOR OFFICE VISIT AND COMPLAINS OF PROGRESSIVELY WORSENING FATIGUE. ASSOCIATED SYMPTOMS INCLUDE FREQUENT URINATION. ASSESSMENT: LOWER URINARY TRACT INFECTION. ON (B)(6) 2014: PATIENT PRESENTED FOR FOLLOW UP VISIT. ASSESSMENT: HTN. ON (B)(6) 2015: PATIENT COMPLAINS OF FLANK DISCOMFORT WITH FREQUENCY OF URINATION AND ALSO COMPLAINS OF LEFT EAR TENDERNESS. ASSESSMENT: SEROUS OTITIS MEDIA, LOWER URINARY TRACT INFECTION, BIPOLAR DISORDER. ON (B)(6) 2015 PATIENT UNDERWENT ECG TEST. RESULT: ABNORMAL ECG. PATIENT PRESENTED FOR OFFICE VISIT WITH CHIEF COMPLAINT OF EXERTIONAL. REVIEW OF SYSTEMS REVEALS FATIGUE, NECK AND BACK PAIN, MEMORY PROBLEMS AND BALANCE PROBLEMS. ON (B)(6) 2015 PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2015 PATIENT PRESENTED FOR OFFICE VISIT WITH CHIEF COMPLAINT OF EXERTIONAL DYSPNEA, EDEMA. ON (B)(6) 2015 PATIENT PRESENTED FOR OFFICE VISIT WITH CHIEF COMPLAINT OF HYPERTENSION, EXERTIONAL DYSPNEA. REVIEW OF SYSTEM REVEALS FEVER, CHILLS, NIGHT SWEATS, FATIGUE, INSOMNIA, DAYTIME, SLEEPINESS, CHRONIC PAIN, MALAISE, NAUSEA, TREMOR, DECREASED APPETITE. ON (B)(6) 2015: PATIENT PRESENTED FOR OFFICE VISIT WITH CHIEF COMPLAINTS OF BACK PAIN. MUSCULOSKELETAL EXAMINATION IS POSITIVE FOR BACK PAIN, DECREASED RANGE OF MOTION, JOINT PAIN, MUSCLE ACHE AND WEAKNESS. PSYCHIATRIC EXAMINATION IS POSITIVE FOR ANXIETY/WORRY, DEPRESSION. ASSESSMENT: KIDNEY FUNCTION STUDY ABNORMALITY, GOUT, FLANK PAIN, BIPOLAR DISORDER. ON (B)(6) 2015: PATIENT PRESENTED FOR FOLLOW UP VISIT. MUSCULOSKELETAL REVIEW OF SYSTEMS IS POSITIVE FOR BACK PAIN, DECREASED RANGE OF MOTION, JOINT PAIN, MUSCLE ACHE AND WEAKNESS. ASSESSMENT: BIPOLAR DISORDER, UTI. ON (B)(6) 2016: PATIENT PRESENTED FOR OFFICE VISIT DUE TO POSS LEFT EAR INFECTION. PATIENT ALSO EXPRESS CONCERNS OF EXCESSIVE FATIGUE. ASSESSMENT: OTITIS MEDIA BILATERAL, KIDNEY FUNCTION STUDY ABNORMALITY, HTN, HYPERLIPIDEMIA, GOUT, FATIGUE. ON (B)(6) 2016: PATIENT PRESENTED FOR FOLLOW UP VISIT. ASSESSMENT: IMPAIRED RENAL FUNCTION, THYROID NODULE, VITAMIN D DEFICIENCY. ON (B)(6) 2016: PATIENT PRESENTS WITH COMPLAIN OF FATIGUE, DEPRESSION AND DIFFICULTY "GETTING OUT OF BED". EXAMINATION: MUSCULOSKELETAL: LOW BACK TENDERNESS WORSE ON THE LEFT AMBULATES WITH CANE. MUSCULOSKELETAL EXAMINATION IS POSITIVE FOR BACK PAIN, DECREASED RANGE OF MOTION,JOINT PAIN, MUSCLE ACHE AND WEAKNESS. ASSESSMENT: DEPRESSION, BIPOLAR DISORDER, RECURRENT UTI, BREAST SCREENING. ON (B)(6) 2016: PATIENT PRESENTED WITH COMPLAINTS OF POSS BRONCHITIS ONSET 1 MONTH. NON PRODUCTIVE COUGH WITH PROGRESSIVE WORSENING. ASSOCIATED SYMPTOMS INCLUDE EAR PRESSURE, DIZZINESS AND SINUS CONGESTION. ASSESSMENT: SINUSITIS, BRONCHITIS. ON (B)(6) 2016: PATIENT PRESENTED WITH COMPLAINTS OF CONTINUED BON PRODUCTIVE COUGH WITH SINUS CONGESTION. PURULENT SINUS DRAINAGE. PATIENT ALSO COMPLAINS OF "KIDNEY HURT". ASSESSMENT: SINUSITIS RECURRENT UTI'S, ALLERGIC RHINITIS. ON (B)(6) 2016: PATIENT PRESENTED FOR OFFICE VISIT DUE TO DIZZINESS AND UTI SYMPTOMS. ASSESSMENT: DIZZINESS AND RECURRENT UTI. ON (B)(6) 2016 PATIENT WAS ADMITTED WITH CHIEF COMPLAINT OF EXERTIONAL DYSPNEA, OLD INFERIOR MI, HYPERLIPIDEMIA. REVIEW OF SYSTEM REVEALS CHRONIC BACK PAIN AND JOINT STIFFNESS. ON (B)(6) 2016 PATIENT WAS ADMITTED WITH CHIEF COMPLAINT OF EXERTIONAL DYSPNEA, OLD INFERIOR MI, HYPERLIPIDEMIA.
IT WAS REPORTED THAT ON: (B)(6) 2011: PATIENT PRESENTED WITH COMPLAINT OF EDEMA, BACK PAIN AND POSSIBLE THRUSH. ASSESSMENT: EDEMA; LUMBAGO; THRUSH. (B)(6) 2011: PATIENT PRESENTED WITH ANXIETY AND MENOPAUSAL DISORDER. ASSESSMENT: ANXIETY STATE; MENOPAUSAL DISORDER. ON (B)(6) 2011: PATIENT PRESENTED WITH COLD SYMPTOMS AND BACK PAIN. ASSESSMENT: ACUTE SINUSITIS; LUMBAGO; DEPRESSIVE DISORDER. ON (B)(6) 2011: PATIENT PRESENTED WITH BACK PAIN, ANEMIA AND ARTHRALGIAS. ASSESSMENT: LUMBAGO; ANEMIA; JOINT PAIN - HAND. ON (B)(6) 2012: PATIENT PRESENTED WITH COMPLAINT OF BACK PAIN, HYPERTENSION AND WEIGHT MEASUREMENT CHECK. ASSESSMENT: LUMBAGO, HYPERTENSION, OBESITY. ON (B)(6) 2012: PATIENT PRESENTED WITH COLD SYMPTOMS AND ABNORMAL MAMMOGRAM. ASSESSMENT: ACUTE SINUSITIS; BREAST DISORDER. ON (B)(6) 2012: PATIENT PRESENTED WITH BACK PAIN, HYPERTENSION, WEIGHT MANAGEMENT CHECK AND ARTHRALGIAS. ASSESSMENT: LUMBAGO; HYPERTENSION; OBESITY; TRIGGER FINGER. ON (B)(6) 2012: PATIENT PRESENTED WITH UTI AND BACK PAIN. ASSESSMENT: URINARY TRACT INFECTION AND LUMBAGO. ON (B)(6) 2012, PATIENT PRESENTED WITH BACK PAIN, SINUSITIS, AND EDEMA. ASSESSMENT: LUMBAGO; ACUTE SINUSITIS AND EDEMA. ON (B)(6) 2012: PATIENT PRESENTED WITH SEVERE BACK PAIN. ASSESSMENT: LUMBAGO; CERVICALGIA. ON (B)(6) 2013: PATIENT PRESENTED WITH COMPLAINT OF COUGH. ASSESSMENT: ACUTE BRONCHITIS. ON (B)(6) 2013: PATIENT PRESENTED WITH COLD SYMPTOMS, COUGH INCLUDING FATIGUE, NASAL CONGESTION, NIGHT SWEATS, POST NASAL DRAINAGE, SINUS PRESSURE AND SORE THROAT. ON (B)(6) 2013: PATIENT PRESENTED WITH COMPLAINT OF HYPERTENSION AND ITS CHECK. ASSESSMENT: LUMBAGO; HYPERTENSION. ON (B)(6) 2013: PATIENT PRESENTED WITH COMPLAINT OF LOW BACK PAIN. ASSESSMENT: LUMBAGO. ON (B)(6) 2013: PATIENT PRESENTED WITH UTI; HYPERTENSION; BACK PAIN; ANXIETY AND MEDICATION REFILL. ASSESSMENT: URINARY TRACT INFECTION; FATIGUE; DIETARY SURVEILLANCE AND COUNSELLING; HYPERTENSION; LUMBAGO; ANXIETY STATE; MIXED HYPERLIPIDEMIA. ON (B)(6) 2014: PATIENT PRESENTED WITH BACK PAIN, GOUT. ASSESSMENT: SPINAL STENOSIS- LUMBAR; GOUT, UNSPECIFIED. ON (B)(6) 2014: PATIENT PRESENTED WITH DEPRESSION AND BACK PAIN. ASSESSMENT: BIPOLAR DISORDER; DEPRESSIVE DISORDER; LUMBAGO. ON (B)(6) 2014: PATIENT PRESENTED FOR FOLLOW UP OF HYPERTENSION AND BIPOLAR. ASSESSMENT: BIPOLAR DISORDER; DEPRESSIVE DISORDER; HYPERTENSION. ON (B)(6) 2014: PATIENT PRESENTED WITH BACK PAIN, "UTI", BIPOLAR, WEIGHT MANAGEMENT. ASSESSMENT: LUMBAGO; BIPOLAR DISORDER. ON (B)(6) 2014: PATIENT PRESENTED WITH BIPOLAR DISORDER, ANXIETY AND BACK PAIN. ASSESSMENT: LUMBAGO; BIPOLAR DISORDER; ANXIETY STATE. ON (B)(6) 2014: PATIENT PRESENTED WITH BACK PAIN AND MOOD SWINGS. ASSESSMENT: LUMBAGO; BIPOLAR DISORDER, UNSPECIFIED; VACCINE FOR DISEASE. ON (B)(6) 2015: PATIENT CAME FOR REFILL ON HER PAIN MEDICATIONS. ASSESSMENT: SPINAL STENOSIS- LUMBAR; HYPERTENSION; GOUT; ATTENTION DEFICIT NON HYPER ACT. ON (B)(6) 2015: PATIENT PRESENTED WITH BACK PAIN. ASSESSMENT: MUSCLE SPASM; DIZZINESS AND GIDDINESS; PARESTHESIA. ON (B)(6) 2015: PATIENT PRESENTED WITH BACK PAIN, PAIN IN FINGERS AND FEET, SINUS SYMPTOMS. ASSESSMENT: LUMBAGO; PARESTHESIA; OBESITY, MORBID; SINUSITIS ACUTE. ON (B)(6) 2015: PATIENT PRESENTED FOR FOLLOW UP OF BACK PAIN, ANXIETY AND SHORTNESS OF BREATH. ASSESSMENT: CERVICALGIA; LUMBAGO; ANXIETY STATE; SHORTNESS OF BREATH; EDEMA. ON (B)(6) 2015: PATIENT PRESENTED FOR FOLLOW UP OF BACK PAIN AND ANXIETY. ASSESSMENT: CERVICALGIA; LUMBAGO; ANXIETY STATE. ON (B)(6) 2015: PATIENT PRESENTED WITH SLEEP APNEA, LETHARGY AND MUSCLE TREMORS. ASSESSMENT: ABNORMAL NEUROLOGICAL EXAM; SLEEP APNEA; HYPERTENSION; HYPOXEMIA. ON (B)(6) 2015: PATIENT UNDERWENT CT OF CHEST. IMPRESSION: NORMAL CT OF SCAN OF THE CHEST WITH NO PULMONARY EMBOLI DEMONSTRATED. ON (B)(6) 2015: PATIENT UNDERWENT CT OF BRAIN DUE TO INDICATION OF ABNORMAL NEUROLOGIC EXAM. SLURRED SPEECH FOR 2 MONTHS. IMPRESSION: NO CT EVIDENCE OF ACUTE INTRACRANIAL HEMORRHAGE. ON (B)(6) 2015: PATIENT PRESENTED WITH WEANING OF LITHIUM. ASSESSMENT: DECREASED RENAL FUNCTION. BIPOLAR DISORDER, UNSPECIFIED. ON (B)(6) 2015: PATIENT PRESENTED WITH BIPOLAR DISORDER AND KIDNEY PAIN. ASSESSMENT: BIPOLAR DISORDER; RENAL PAIN. ON (B)(6) 2015: PATIENT PRESENTED WITH COMPLAINT OF BACK PAIN, ANXIETY AND FOLLOW UP OF SLEEP STUDY RESULTS. ASSESSMENT: ANXIETY STATE; LUMBAGO; CERVICALGIA; SLEEP APNEA; DECEASED (B)(6) 2015: PATIENT PRESENTED WITH COMPLAINT OF BACK PAIN. ASSESSMENT: LUMBAGO; CERVICALGIA; ANXIETY STATE; GOUT. ON (B)(6) 2015: PATIENT PRESENTED WITH COMPLAINT OF BACK PAIN. ASSESSMENT: LUMBAGO. ON (B)(6) 2015: PATIENT PRESENTED WITH COMPLAINT OF BACK PAIN AND RELATIONSHIP PROBLEMS. ASSESSMENT: BILATERAL LOW BACK PAIN WITH SCIATICA; CERVICALGIA; SHORTNESS OF BREATH. ON (B)(6) 2015: PATIENT PRESENTED FOR FOLLOW UP OF WHEEZING, NEUROPATHY AND MOOD DISORDER. ASSESSMENT: BIPOLAR II DISORDER; LOW BACK PAIN; FAILED BACK SURGICAL SYNDROME. ON (B)(6) 2016: PATIENT PRESENTED WITH AN INJURY. ASSESSMENT: SPRAIN OF THE OTHER LIGAMENT OF RIGHT ANKLE, INITIAL ENCOUNTER. PATIENT UNDERWENT X-RAY OF COMPLETE ANKLE DUE TO PAIN, TRAUMA. IMPRESSION: TINY CHIP AVULSION FRACTURE OF THE DISTAL TIP LEFT LATERAL MALLEOLUS. CLOSED INJURY. OVERLYING LEFT ANKLE SOFT TISSUE SWELLING AND SMALL EFFUSION. CALCANEAL SPURS. ON (B)(6) 2016: PATIENT PRESENTED WITH AN INJURY. ASSESSMENT: AVULSION FRACTURE OF ANKLE, LEFT, CLOSED WITH ROUTINE HEALING, SUBSEQUENT ENCOUNTER. PATIENT UNDERWENT X-RAY OF COMPLETE ANKLE 3 WEEKS POST FRACTURE. IMPRESSION: SMALL LATERAL MALLEOLAR CHIP FRACTURE AGAIN IDENTIFIED. ON (B)(6) 2016: PATIENT PRESENTED WITH MUSCULOSKELETAL PAIN. ASSESSMENT: AVULSION FRACTURE OF ANKLE, LEFT, CLOSED WITH ROUTINE HEALING, SUBSEQUENT ENCOUNTER. PATIENT UNDERWENT X-RAY OF COMPLETE ANKLE DUE TO INJURY. IMPRESSION: STABLE SMALL FRACTURE BORDERING THE LATERAL MALLEOLUS.
IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT PRESENTED WITH MINOR BILATERAL LOWER EXTREMITY EDEMA. PATIENT UNDERWENT BILATERAL LOWER EXTREMITY VENOUS DUPLEX EXAM. SUMMARY: NORMAL BILATERAL LOWER EXTREMITY SUPERFICIAL AND DEEP VENOUS EXAM. ON (B)(6) 2011: ON A TELEPHONIC CONVERSATION, PATIENT STATED THAT HER LEGS ARE SWOLLEN. ON (B)(6) 2013: THE PATIENT PRESENTED FOR OFFICE VISIT DUE TO LOW BACK PAIN AND PAIN GOING DOWN THE LEFT LEG TO KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224896 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M111064AAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |