INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2013-00170
- Event Type
- Injury
- Date Received
- January 18, 2013
- Report Date
- May 25, 2016
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
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)(4).
(B)(4).
(B)(4)
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT UNSPECIFIED SURGERY USING RHBMP-2/ACS. REPORTEDLY, THE PATIENT HAS "SERIOUS PAIN," FREQUENTLY VISITS DOCTOR AND IS AFRAID SHE WILL NEED ANOTHER SURGERY.
IT WAS REPORTED THAT ON (B)(6) 2008: THE PATIENT WAS ADMITTED WITH CHIEF COMPLAINT OF BACK PAIN/INSTRUMENTATION ANTERIOR LUMBAR. THE PATIENT PRESENTED WITH PRE-OP AND POST-OP DIAGNOSIS - 1. PSEUDOARTHROSIS, L4-5, AND 2. PSEUDOARTHROSIS, L5-S1. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR EXPOSURE OF THE LUMBAR SPINE. ANTERIOR LUMBAR INTERBODY FUSION OF PSEUDOARTHROSIS, L4-5, WITH RHBMP-2 BONE MORPHOGENIC PROTEIN. REMOVAL OF INTERBODY DEVICE, L5-S1. ANTERIOR LUMBAR INTERBODY FUSION WITH STRUCTURAL ALLOGRAFT BONE AND RHBMP-2 BONE MORPHOGENIC PROTEIN. ANTERIOR LUMBAR INSTRUMENTATION AT L5-S1 WITH PLATING SYSTEM. INSPECTION OF FUSION AT L4-5, L5-S1. AS PER-OP NOTES: "....SIGNIFICANT AMOUNT OF INFLAMMATORY TISSUE ADJACENT TO THE DISC SPACES WAS NOTED BOTH AT L4-5 AND L5-S1. SPINE WAS EXPOSED. SHARP ANNULOTOMY WAS PERFORMED AT L4-5 LEVEL. ALL COMPONENTS OF THE DISK ANTERIOR TO INTERBODY GRAFT WAS REMOVED. IT DID APPEAR TO HAVE A PARTIAL FUSION, PARTICULARLY SUPERIORLY AT L4 VERTEBRAL BODY AND PLATE. IT WAS FELT THAT THIS WAS COMPLETE INCOMPLETE FUSION, THEN IT WAS SUPPLEMENTED WITH 2 SPONGES, PREPARED WITH RHBMP-2 BONE MORPHOGENIC PROTEIN. THESE WERE LAID AROUND THE GRAFT IN THE AREAS ADJACENT TO THE PSEUDOARTHROSIS. NEXT, ANNULOTOMY WAS PERFORMED AT L5-S1 LEVEL. THE GRAFTS WERE NOTED TO BE SIGNIFICANTLY LOOSE. THEY WERE REMOVED. ENDPLATE PREPARATION WAS PERFORMED TO PUNCTATE BLEEDING BONE. A 14 MM ALLOGRAFT BONE WAS PLACED INTO THE INTERBODY SPACE USING CATALYST SYSTEM. THE FEMORAL RING THAT WAS USED WAS PACKED WITH A SPONGE USING RHBMP-2 BONE MORPHOGENIC P ROTEIN. A PLATE WAS PLACED OVER THE L5 AND S1 LEVELS WITH ONE SCREW PLACED IN THE L5 AND TWO IN S1. THE LOCKING PLATE WAS ATTACHED TO THE PLATE ITSELF. THE WOUND WAS CLOSED, STERILE DRESSINGS WERE APPLIED� THE PATIENT WAS TRANSFERRED TO RECOVERY IN GOOD CONDITION. THE PATIENT UNDERWENT X-RAY OF LUMBAR SPINE- ANTERIOR POSTERIOR DUE TO ANTERIOR FUSION L5-S1, EXPLORATION OF L4-5 FUSION. FINDINGS: BILATERAL SCREWS AT L4-5 AND L5-S1 WERE CONNECTED BY POSTERIOR RODS. ANTERIOR CORTICAL PLATE AND SCREWS WERE PRESENT AT L5-S1 LEVEL. INTER-VERTEBRAL CAGE/S WERE NOTED AT L5-S1 LEVEL. ALIGNMENT WAS UNREMARKABLE. ON (B)(6) 2008: THE PATIENT WAS DISCHARGED HOME IN SATISFACTORY CONDITION. ON (B)(6) 2008: ON A TELEPHONIC CONVERSATION, THE PATIENT COMPLAINED OF LOT OF PAIN. ON (B)(6) 2008: THE PATIENT PRESENTED FOR FOLLOW-UP POST REVISION SURGERY OF BACK DUE TO PSEUDOARTHROSIS. ON (B)(6) 2008: ON A TELEPHONIC CONVERSATION, THE PATIENT REPORTS THAT THE INCISION WAS FINE AND NOT DRAINING. THE PATIENT FELT SICK (FEVERISH). ON (B)(6) 2008: THE PATIENT PRESENTED FOR AN OFFICE VISIT. THE PAIN WAS IMPROVING. ON (B)(6) 2008: THE PATIENT PRESENTED FOR FOLLOW-UP POST SECOND BACK SURGERY. ON (B)(6) 2008: THE PATIENT PRESENTED FOR FOLLOW-UP POST BACK REVISION SURGERY WITH BACK PAIN. ON (B)(6) 2009: THE PATIENT PRESENTED FOR FOLLOW-UP. IMPRESSION: CHRONIC NECK AND UPPER BACK PAIN. LOWER BACK PAIN. STATUS POST PLIF AT L5-5 AND L5-S1. PSEUDOARTHROSIS OF THE LUMBAR REGION THAT REQUIRED A SECOND SURGERY. CHRONIC OPIOID USE FOR PAIN CONTROL. DEPRESSION. ON (B)(6) 2009: THE PATIENT PRESENTED FOR FOLLOW - DUE TO CHRONIC LOWER BACK PAIN AND HAD BACK SURGERY. IMPRESSION: CHRONIC LOWER BACK PAIN. FIRST BACK SURGERY WITH PSEUDO ARTHROSIS AT L5-S1 REQUIRING A SECOND BACK SURGERY AS AN ANTERIOR EXPOSURE AT L4-5 AND L5-S1 AND FUSION. CHRONIC OPIOID USE. ON (B)(6) 2009: THE PATIENT PRESENTED FOR FOLLOW-UP DUE TO CHRONIC LOWER BACK PAIN AND HAD TWO BACK SURGERIES. ON (B)(6) 2011, (B)(6) 2012: THE PATIENT PRESENTED FOR AN OFFICE VISIT WITH CHIEF COMPLAINT OF CHRONIC LOW BACK PAIN, NECK PAIN, DEPRESSION, CHRONIC OPIOID THERAPY. ON (B)(6) 2013: THE PATIENT UNDERWENT X-RAY OF CERVICAL SPINE DUE TO CHRONIC LOW BACK PAIN. IMPRESSION: NO ACUTE OSSEOUS ABNORMALITY. THE PATIENT ALSO UNDERWENT X-RAY OF ANTERIOR POSTERIOR LUMBAR SPINE DUE TO CHRONIC LOW BACK PAIN. IMPRESSION: PRIOR LOWER LUMBAR FUSION WITH FRACTURE OF THE POSTERIOR S1 SCREW, BUT THIS WAS UNCHANGED. ON (B)(6) 2013: THE PATIENT PRESENTED FOR AN OFFICE VISIT WITH CHIEF COMPLAINT OF BACK PAIN AND LEFT GREATER THAN RIGHT LEG PAIN. THE PATIENT UNDERWENT PHYSICAL EXAMINATIONS. IMPRESSION: LUMBAR RADICULOPATHY, STATUS POST TRAUMA, STATUS POST MULTIPLE BACK SURGERIES. ON (B)(6) 2013: THE PATIENT UNDERWENT MYELOGRAM OF LUMBAR SPINE DUE TO BACK PAIN AND LEFT LEG PAIN. IMPRESSION: POST-OPERATIVE CHANGES CONSISTENT WITH L4 AND L5 LAMINECTOMIES WITH INTERBODY, ANTERIOR AND POSTERIOR FUSION AND NO DEFINITIVE EXISTING NERVE ROOT IMPINGEMENT. ANNULAR BULGE AT L3-L4 MORE PRONOUNCED ON THE LEFT BUT WITHOUT DEFINITIVE NERVE ROOT IMPINGEMENT OR SIGNIFICANT CENTRAL SPINAL STENOSIS. BROADENED NON-SPECIFIC SOFT TISSUE DENSITY WITHIN THE LEFT NEURAL FORAMEN AT THE L5-S1 LEVEL MOST LIKELY REPRESENTING GRANULATION AND/OR SCAR TISSUE ADJACENT TO AND/OR EXTENDING FROM THE NERVE ROOT. ON (B)(6) 2013: THE PATIENT PRESENTED FOR AN OFFICE VISIT WITH CHIEF COMPLAINT OF LOW BACK AND LOWER EXTREMITY PAIN AND HEAD PAIN. THE PATIENT UNDERWENT MYELOGRAM. IMPRESSION: FAILED BACK SURGERY WITH MORE RECENT TRAUMA. THE MUSCULOSKELETAL STUDY INDICATED SEVERELY LIMITED RANGE OF MOTION IN THE LUMBAR SPINE. THE PATIENT HAD PARA-SPINOUS TENDERNESS, WORSE ON THE LEFT, SOME LEFT PIRIFORMIS TENDERNESS. STRAIGHT LEG RAISES ARE NEGATIVE. ACCORDING TO THE NEUROLOGICAL STUDIES, THE PATIENT HAD DECREASED SENSATION OVER THE LATERAL ASPECT OF BOTH KNEES AND TO SOME DEGREE OVER THE TIBIAL SURFACES. LOWER EXTREMITIES-GAIT WAS GROSSLY ANTALGIC. ON (B)(6) 2013: THE PATIENT UNDERWENT MRI DUE TO HEADACHES AND BLURRED VISION.
IT WAS REPORTED THAT ON (B)(6) 2008: THE PATIENT UNDERWENT RADIOGRAPHIC STUDY OF ABDOMEN DUE TO ABDOMINAL PAIN. IMPRESSION: FECAL RETENTION. ON (B)(6) 2010: THE PATIENT UNDERWENT MRI OF LUMBAR SPINE WITH/WITHOUT CONTRAST DUE TO LOW BACK AND RIGHT LEG PAIN. CONCLUSION: STATUS POST LAMINECTOMY WITH ANTERIOR-POSTERIOR SPINE FUSION L4-L5, L5-S1 WITHOUT CENTRAL CANAL STENOSIS, FORAMINAL STENOSIS OR NERVE ROOT COMPRESSION. CEPHALAD TO THE FUSION IS BORDERLINE MILD MULTIFACTORIAL CENTRAL CANAL STENOSIS L3-L4 WITH GENTLE ABUTMENT OF THE DESCENDING L4 NERVE ROOTS BILATERALLY RIGHT GREATER THAN LEFT. NON COMPRESSIVE CENTRAL DISC DISPLACEMENT T11-T12. ON (B)(6) 2011: THE PATIENT UNDERWENT MRI OF CERVICAL SPINE DUE TO NECK PAIN , LEFT UPPER PARESTHESIA AND HEADACHES. IMPRESSION: RIGHT PARA-CENTRAL TO PROXIMAL FORAMINAL ANNULAR PROTRUSION AT C6-C7 WITHOUT DEFINITIVE NERVE ROOT IMPINGEMENT. MILD MULTI-LEVEL DEGENERATIVE SPONDYLOSIS WITH NO FOCAL DISC HERNIATION ON THE LEFT OR DEFINITIVE EXITING NERVE ROOT IMPINGEMENT. NORMAL APPEARANCE OF THE CERVICAL AND UPPER THORACIC SPINAL CORD. ON (B)(6) 2013: THE PATIENT ALSO UNDERWENT CT OF LUMBAR SPINE DUE TO BACK PAIN AND LEFT LEG PAIN. IMPRESSION: POST-OPERATIVE CHANGES CONSISTENT WITH L4, L5 AND S1 LAMINECTOMIES AS SEEN ON PREVIOUS EXAMINATION WITH NO CENTRAL CANAL NARROWING. THERE IS NOW SOLID INTER-BODY FUSION AT L4-5 AND L5-S1 WITH INTERVAL ANTERIOR FUSION AT THE L5-S1 LEVEL. POSTERIOR FUSION WITH TRANS-PEDICULAR SCREWS TRANSFIXING THE L4, L5 AND S1 VERTEBRA APPEAR UNCHANGED IN POSITION WITH SIMILAR FRACTURES OF THE SCREWS BILATERALLY AT THE S1 LEVEL. BROADENED NON-SPECIFIC SOFT TISSUE DENSITY WITHIN THE LEFT NEURAL FORAMEN AT THE L5-S1 LEVEL MOST LIKELY REPRESENTING GRANULATION AND/OR SCAR TISSUE ADJACENT TO AND/OR EXTENDING FROM THE NERVE ROOT. IN ADDITION, THERE IS INCREASED BONY HYPERTROPHY INVOLVING THE RIGHT FORAMEN AT L5-S1 BUT WITH NO DEFINITIVE RIGHT L5 NERVE ROOT IMPINGEMENT. MILD ANNULAR BULGE AT THE L3-L4 LEVEL WITH NO SIGNIFICANT CENTRAL SPINAL STENOSIS OR NERVE ROOT IMPINGEMENT OR SIGNIFICANT CHANGE. ON (B)(6) 2013, THE PATIENT PRESENTED WITH COMPLAINT OF HEADACHE AND WAS ON CHRONIC NARCOTIC PAIN MEDICATION. ON (B)(6) 2013: THE PATIENT UNDERWENT RADIOGRAPHIC EXAMINATION OF CERVICAL SPINE DUE TO CHRONIC LOW BACK PAIN AND BACK SURGERY. THE RESULTS WERE COMPARED TO THE MRI DATED ON (B)(6) 2011. IMPRESSION: NO ACUTE OSSEOUS ABNORMALLY. ON (B)(6) 2013: THE PATIENT UNDERWENT RADIOGRAPHIC STUDY OF ANTERIOR POSTERIOR AND LATERAL SPINE DUE TO BACK PAIN. THE RESULTS WERE COMPARED TO THAT OBTAINED ON (B)(6) 2013. IMPRESSION: POST-OPERATIVE CHANGES SIMILAR TO PREVIOUS EXAM. NO ACUTE PATHOLOGY SEEN. CALCIFICATION OVERLIES LEFT KIDNEY. ON (B)(6) 2015: THE PATIENT UNDERWENT RADIOGRAPHIC EXAMINATION OF CHEST DUE TO CHEST PAIN. IMPRESSION: NO ACUTE CARDIOPULMONARY PROCESS. ON (B)(6) 2015: PATIENT PRESENTED WITH DIAGNOSIS OF CRITICAL LIMB ISCHEMIA ¿ CARDIOLOGY. ASSESSMENT: SEVERE CARDIOMYOPATHY, TOBACCO ABUSE, MINIMAL CORONARY ARTERY DISEASE, MILD EDEMA. PATIENT UNDERWENT ECHO TEST (ECHOCARDIOGRAPHY). ON (B)(6) 2015: PATIENT UNDERWENT ADULT ECHOCARDIOGRAM STUDY. CONCLUSIONS: THERE IS MODERATE TO SEVERE GLOBAL HYPOKINESIS OF THE LEFT VENTRICLE. THE VISUALLY ESTIMATED EJECTION IS 25-30%. THERE IS BORDERLINE LEFT VENTRICULAR HYPERTROPHY. ON (B)(6) 2015: PATIENT PRESENTED WITH CHIEF COMPLAINT OF SEVERE CARDIOMYOPATHY, DYSPNEA WITH ACTIVITY, HEART FAILURE. IMPRESSION: TOBACCO DEPENDENCE, ANXIETY, CONSISTENT NARCOTIC USE, PALPITATIONS, POSSIBLE SLEEP APNEA. ON (B)(6) 2015: PATIENT PRESENTED FOR MONITORING AND VENTRICULAR TACHY THERAPY. ON (B)(6) 2016: PATIENT PRESENTED WITH CHIEF COMPLAINT OF CARDIOMYOPATHY, HYPERTENSION AND ICD CHECK. REPORTEDLY, SHE WAS NOTICED TO HAVE SEVERE LV SYSTOLIC DYSFUNCTION. ASSESSMENT: CARDIOMYOPATHY.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION SURGERY FROM L4 TO S1 ON (B)(6) 2008 USING RHBMP-2/ACS. THE RHBMP-2/COLLAGEN SPONGE WAS PLACED IN THE DISC SPACE. SOMETIME POSTOP, THE PATIENT REPORTEDLY EXPERIENCED LOW BACK PAIN AND WEAKNESS IN HER LOWER EXTREMITIES.A CT MYELOGRAM SCAN PERFORMED ON (B)(6), 2013, REVEALED BONY OVERGROWTH IMPINGING ON THE PATIENT铠SPINE AT THE LEVEL OF IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27583 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M110705AAC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |