INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2014-00145
- Event Type
- Injury
- Date Received
- January 16, 2014
- Report Date
- May 11, 2015
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, 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.
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) 2004 THE PATIENT REPORTEDLY UNDERWENT MRI WHICH DEMONSTRATED A LARGE HERNIATED DISK AT THE LEVEL C5-6 WITH A LARGE OSTEOPHYTE CAUSING SIGNIFICANT COMPRESSION OF THE SPINAL CORD. THE AP DIAMETER OF THE SPINAL CANAL WAS MARKEDLY DECREASED CAUSING A MARKED AND SIGNIFICANT COMPRESSION OF THE SPINAL CORD. THERE WAS EVIDENCE OF A HERNIATED DISC AT THE LEVEL C4-5 CAUSING SPINAL CORD COMPRESSION. THERE WAS EVIDENCE OF MYELOMALACIA. THERE WAS AN ALTERED SIGNAL WITH THE SPINAL CORD AT THE LEE OF C5-6. ON (B)(6) 2004 THE PATIENT PRESENTED WITH NECK PAIN AND ARM RADICULOPATHY. THE PATIENT UNDERWENT A C1-2 CERVICAL MYELOGRAM WITH C1- 2 PUNCTURE WHICH SHOWED A SEVERELY ABNORMAL CERVICAL MYELOGRAM AT C5-6 PRIMARILY TO THE LEFT. A POST MYELOGRAPHIC CT OF THE CERVICAL SPINE SHOWED MULTIPLE DISC HERNIATIONS, THE WORSE ONE BEING C5-6 WITH THE COMBINATION OF A HARD AND PROBABLY SOFT DISC WITH SIGNIFICANT DEFORMITY AND COMPRESSION OF THE SPINAL CORD. THERE WAS A SMALLER DISC HERNIATION IDENTIFIED AT C6-7 AND C4-5 WITH PROMINENCE OF THE C3-4 DISC AS WELL. ON (B)(6) 2004 LABS REVEALED LOW HGB, HCT, MCV, MCH, MPV AND HIGH RDW AND PLATELETS. AN ECG WAS RUN WHICH SHOWED BORDERLINE CHANGES POSSIBLY DUE TO MYOCARDIAL ISCHEMIA. ON (B)(6) 2004 LABS REVEALED LOW HGB, HCT, MCV, MCH, AND BILIRUBIN AND HIGH RDW, PLATELETS, AND GLUCOSE. ON (B)(6) 2004 THE PATIENT PRESENTED WITH NECK PAIN AND DIFFICULTY AMBULATION WITH CERVICAL STENOSIS AND MYELOPATHY. PREOPERATIVE LABS WERE TAKEN WHICH SHOWED A RELATIVELY STABLE HEMOGLOBIN A1C. AN ELECTROCARDIOGRAM TAKEN WAS NORMAL. A NOTE WAS MADE IN THE ENCOUNTER NOTES THAT THE PATIENT HAD UNDERGONE STRESS TEST AND CARDIAC CATHETERIZATION THE YEAR BEFORE WHICH WAS UNREMARKABLE. THE PATIENT WAS CLEARED FOR SURGERY. THE PATIENT UNDERWENT SURGERY WHICH CONSISTED OF AN ANTERIOR CERVICAL DECOMPRESSION, FUSION, C5-6 WITH PLATING. IT SHOULD BE NOTED THAT THERE WERE SIGNIFICANT OSTEOPHYTES NOTED THROUGHOUT AND THERE WAS AN OSTEOPHYTE OF POSTERIOR LONGITUDINAL LIGAMENT WHICH WAS ATTACHED TO THE DURA AND DURING THE PROCESS OF REMOVING THE POSTERIOR LONGITUDINAL LIGAMENT, THERE WAS MINOR LEAKAGE. A SMALL PIECE OF GELFOAM WAS PLACED OVER THIS TEAR AND THERE WAS NO FURTHER LEAKAGE. NO OTHER COMPLICATIONS WERE REPORTED. PATHOLOGIES OF BIOPSY MATERIAL WERE UNREMARKABLE. ON (B)(6) 2004 THE PATIENT PRESENTED FOR A POST OP STUDY. THE PATIENT UNDERWENT A CERVICAL SPINE CT SCAN WHICH SHOWED PERSISTENT POSTERIOR OSTEOPHYTES ASSOCIATED WITH THE INFERIOR C5, SUPERIOR C6 AND INFERIOR C7 ENDPLATES WERE UNCHANGED COMPARED TO (B)(6) 2004. ON (B)(6) 2004 THE PATIENT WAS DISCHARGED FORM HOSPITAL. ON (B)(6) 2004 THE PATIENT PRESENTED WITH CERVICAL STENOSIS WITH MYELOPATHY. THE PATIENT WAS POST OP AND IT WAS REPORTED THAT A POS T-OPERATIVE CAT SCAN SHOWED PERSISTENCE OF THE COMPRESSION. THE PATIENT REPORTED THAT THEY HAD NOT GOTTEN BETTER. THE PATIENT WAS ADMITTED TO HOSPITAL FOR COMPLETION OF DECOMPRESSION AND STABILIZATION THE NEXT DAY. ON (B)(6) 2004 THE PATIENT PRESENTED WITH GENERALIZED WEAKNESS OF BOTH ARMS AND LEGS AND NUMBNESS OF BOTH ARMS, RIGHT > LEFT. THE PATIENT COMPLAINED OF TINGLING AND NUMBNESS OF THE THIGH ON THE RIGHT SIDE AND DIFFICULTY WITH BALANCE. THE PATIENT UNDERWENT AN ECG WHICH WAS NORMAL. THE PATIENT HAD THE PREOPERATIVE DIAGNOSIS OF CERVICAL MYELOPATHY AND CERVICAL SPINAL STENOSIS DUE TO A LARGE HERNIATED DISC AT THE LEVEL OF C4-5 AS WELL AS C5-6. THE PATIENT UNDERWENT SURGERY WHICH CONSISTED OF A REMOVAL OF PREVIOUS ANTERIOR CERVICAL FUSION PLATE AND SCREWS AND BONE GRAFT AT THE LEVEL OF C5-6, ANTERIOR CERVICAL CORPECTOMY OF C5-6, ANTERIOR CERVICAL FUSION FROM C4 TO C6 USING THE FIBULAR BONE GRAFT, AND SPINAL INSTRUMENTATION AND STABILIZATION WITH PLATE AND SCREWS. IT SHOULD BE NOTED THAT PER THE OPERATIVE REPORT DURING THE SURGERY: A COLLECTION OF CSF ALL THE WAY DOWN TO THE PREVERTEBRAL SPACE WAS REVEALED AND DRAINED; FOUND: A OPENING INTO THE DURA MATER ON THE LEFT SIDE FROM PREVIOUS SURGERY JUST ABOUT THE NERVE ROOT JUST ON TOP OF THE NERVE ROOT AT THE LEVEL OF C5-6 ON THE LEFT SIDE FROM WHICH THE CSF WAS LEAKING OUT. THE HOLE WAS ABOUT 3 MM X 2 MM SIZE; FOUND: AN OSTEOPHYTE AT THE LEVEL OF C5-6 AS WELL AS C4-5 WAS CAUSING SIGNIFICANT COMPRESSION OF THE SPINAL CORD AND WAS STUCK TO THE POSTERIOR LONGITUDINAL LIGAMENT, AND THE POSTERIOR LONGITUDINAL LIGAMENT WAS ALSO SOMEWHAT CALCIFIED. IT WAS ADHERENT TO THE DURA MATER. THIS OSTEOPHYTE WAS REMOVED; THE SPINAL CORD AND NERVE ROOTS WERE DECOMPRESSED VERY WELL BILATERALLY; THE HOLE INTO THE DURA MATER WAS SUCH THAT THERE WAS NO WAY IT COULD BE REPAIRED PRIMARILY, SO PLACED WAS A SMALL PIECE OF GELFOAM OVER THAT, AND A PIECE OF DURAGEN WAS APPLIED OVER THAT, AND WATERTIGHT CLOSURE OF THE DURA MATER WAS ACHIEVED. NO OTHER COMPLICATIONS WERE REPORTED. CERVICAL SPINE X-RAYS DEMONSTRATED INSTRUMENTATION IN PROPER POSITION WITH THE EXCEPTION OF C7 WHICH WAS NOT WELL SEEN. ON (B)(6) 2004 THE PATIENT UNDERWENT CHEST X-RAYS WHICH SHOWED NO EVIDENCE OF ACTIVE LUNG DISEASE. ON (B)(6) 2004 THE PATIENT PRESENTED WITH CERVICALGIA AND UNDERWENT CERVICAL SPINE X-RAYS WHICH, WHEN COMPARED TO PREVIOUS X-RAYS, SHOWED ANTERIOR FUSION AT C4-C5 AND C5-C6 ANTERIORLY IMMOBILIZED BY PLATE AND SCREWS AT THE LEVELS OF THE C4 AND C6. ALSO NOTED: POSTERIORLY PEDICLE SCREWS AT THE LEVELS OF C4, C5 AND C6 BILATERALLY WITH ROD IMMOBILIZING THE FIXATION DEVICE. THERE WAS MINIMAL SUBCUTANEOUS AIR NOTED IN THE NECK. THERE APPEARED TO BE MULTIPLE VASCULAR SURGICAL CLIPS ANTERIORLY AND RIGHT LATERALLY. ALIGNMENT OF THE CERVICAL SPINE APPEARED ANATOMICAL. ON (B)(6) 2004 THE PATIENT PRESENTED WITH PROGRESSIVE PAIN AND DISCOMFORT. THE PATIENT ALSO PRESENTED WITH ANEMIA. ON (B)(6) 2004 THE PATIENT WAS TRANSFERRED INTO A PHYSICAL REHABILITATION PROGRAM. THE PATIENT COMPLAINED OF CONSTIPATION, AND ANXIETY. T ON (B)(6) 2004 THE PATIENT WAS DISCHARGED FROM HOSPITAL. THE DIAGNOSIS LISTED ON DISCHARGE WAS: OF CERVICAL MYELOPATHY, MOBILITY DYSFUNCTION, DECREASED ACUITIES OF DAILY LIVING, CERVICAL SPINE, POST CERVICAL SPINE DECOMPRESSIVE SURGERY, DIABETES MELLITUS, HYPERTENSION, HYPOTHYROIDISM, DEGENERATIVE ARTHRITIS, AND POST OP ANEMIA. ON (B)(6) 2005 THE PATIENT PRESENTED WITH MYELOPATHY AND CERVICAL COMPRESSION. THE PATIENT REPORTED IMPROVED SYMPTOMS. THE PATIENT WAS UTILIZING A WALKER FOR AMBULATION DUE TO LEFT KNEE PROBLEMS. X-RAYS OF THE CERVICAL SPINE SHOWED THE ALLOGRAFT ANTERIORLY IN EXCELLENT POSITION WITH HARDWARE PLACEMENT AND POSTERIOR INSTRUMENTATION. THE PATIENT WAS TO WEAR A BRACE FOR 2 MONTHS. THE PATIENT WAS TAKEN OFF WORK. ON (B)(6) 2005 THE PATIENT PRESENTED WITH SIGNIFICANT IMPROVEMENT IN HER NEUROLOGICAL CONDITION. THE PATIENT WAS WEARING A CERVICAL COLLAR. THE PATIENT REPORTED THAT THEIR LEFT LEG WAS GIVING OUT A BIT AND STILL HAD SOME WEAKNESS OF BOTH HAND GRIPS. ON (B)(6) 2005 THE PATIENT PRESENTED SOME DISCOMFORT IN THE NECK WITH SOME RESTRICTED MOVEMENT. THERE WAS IMPROVED STRENGTH IN BOTH ARMS. THE PATIENT AMBULATED WITH HELP OF THE WALKER. ON (B)(6) 2007 THE PATIENT PRESENTED FOR A PRE-OP EVALUATION. IN THE ENCOUNTER NOTES IT MENTIONED THAT THE PATIENT HAD BEEN ¿¿VERY MUCH OUT OF CONTROL WITH THE DIABETES IN THE PAST¿¿ ON (B)(6) 2007 THE PATIENT UNDERWENT A LEFT KNEE ARTHROSCOPY. ON (B)(6) 2007 THE PATIENT PRESENTED IN ER WITH LEFT KNEE SWELLING, REDNESS AND PAIN POST ARTHROSCOPY. THE PATIENT HAD DIFFICULTY WITH WEIGHT BEARING. THE KNEE WAS ASPIRATED AND THE INITIAL ASPIRATE GRAM STAINED REVELED A RARE GRAM POSITIVE COCCI. IT WAS REPORTED THAT AN ARTHROSCOPIC STUDY COMPLETED SEVERAL DAYS PRIOR HAD SHOWN SOME CARTILAGE DERANGEMENT. X-RAYS OF THE LEFT KNEE SHOWED A MILD TRI-COMPARTMENTAL OSTEOARTHRITIS AND A SMALL SUPRAPATELLAR JOINT EFFUSION. THE PATIENT WAS ADMITTED TO HOSPITAL. ON (B)(6) 2007 THE PATIENT PRESENTED FOR A CONSULTATION ON LEFT KNEE PAIN AND SWELLING. PER THE ENCOUNTER NOTES THE INITIAL ASPIRATE FINDINGS WERE CHANGED TO NO ORGANISMS SEEN. THE PATIENT REPORTED FEELING BETTER AFTER 24 HRS OF ANTIBIOTICS AND WAS ABLE TO WEIGHT BEAR. ASSESSMENT: EFFUSION AND CELLULITIS. THERE WAS CONSIDERATION FOR A POSSIBLE ARTHROSCOPY AND LAVAGE HOWEVER THE PATIENT DECLINED. ON (B)(6) 2007 THE PATIENT WAS DISCHARGED FROM HOSPITAL. ON (B)(6) 2010 THE PATIENT PRESENTED WITH CERVICALGIA AND UNDERWENT CERVICAL X-RAYS WHICH SHOWED (COMPARED TO (B)(6) 2004) A STABLE POSITION AND ALIGNMENT OF THE COMPLEX ANTERIOR AND POSTERIOR BONY AND HARDWARE FUSION OF THE C4 TO C6 LEVELS. THIS INCLUDED AN ANTERIOR FUSION PLATE FIXED WITH PAIRED TRANSCORPOREAL SCREWS AT THE C4 AND C6 LEVELS AS WELL AS APPARENT INTERCALARY BONE STRUT GRAFT EXTENDING FROM C4 TO C6 AS WELL AS BILATERAL POSTERIOR BONY FUSION WITH TRANSPEDICULAR SCREWS AT C4, CS AND C6 AND INTERVENING FIXATION RODS. THERE WERE SURGICAL CLIPS SEEN IN THE ANTERIOR NECK SOFT TISSUES. THE ALIGNMENT OF THE SEGMENTS WAS NORMAL AND THE BALANCE OF THE VERTEBRAL BODY DISK HEIGHTS WAS MAINTAINED. NO ACUTE FRACTURE OR SUBLUXATION WAS SEEN. FROM (B)(6) 2011 THROUGH (B)(6) 2012 THE PATIENT PARTICIPATED IN MULTIPLE PHYSICAL THERAPY SESSIONS. ON (B)(6) 2011 THE PATIENT PRESENTED WITH GAIT DEVIATION AND DECREASED BALANCE. THE PATIENT COMPLAINED OF PAIN IN THE NECK AND SPASMS IN THE LOW BACK RADIATING ANTERIORLY TO BOTH KNEES, THE PATIENT ALSO REPORTED GENERAL WEAKNESS. THE PATIENT HAD DECREASED SUPPLENESS IN THE RIGHT LOWER LEG COMPARED TO THE LEFT. THE PATIENT ALSO HAD DECREASED SENSATION IN THE RIGHT HAND FINGERS, MEDIAL FOREARM, ARM, RIGHT MEDIAL AND POSTERIOR LOWER LEG AND PLANTAR SURFACE OF THE FOOT. ON (B)(6) 2012 THERE WAS AN ORDER FOR A PHYSICAL THERAPY 2X6 WEEKS. ON (B)(6) 2012 THE PATIENT PRESENTED IN PT WITH LEFT KNEE JOINT PAIN, OSTEOARTHRITIS, LATERAL MENISCUS DERANGEMENT AND DIFFICULTY WALKING. PER THE EVALUATION NOTES THE PATIENT HAD A HISTORY OF DECREASED SENSATION DOWN THE SHIN AND A BURNING SENSATION ON THE LATERAL ASPECT OF THE KNEE. IT WAS REPORTED THAT THE PATIENT HAD RECENTLY RECEIVED A CORTISONE INJECTION WHICH IMPROVED SYMPTOMS AFTER A WEEK. THERE HAD BEEN REPORTS OF BUCKLING PRIOR TO THE SHOT. PRIOR TO THE SHOT THE PATIENT HAD COMPLAINED OF CONSTANT PAIN IN THE LEFT KNEE. THAT PAIN WAS NOW REPORTED AS INTERMITTENT. THE PATENT ALSO COMPLAINED OF DECREASED BALANCE, INABILITY TO PERFORM MOST ACTIVITIES OF DAILY LIVING, AND DECREASED TOLERANCE FOR AMBULATION. ON PALPITATION, ATROPHY WAS NOTED IN BOTH LOWER EXTREMITIES, ESPECIALLY THE QUADS. THE PATIENT HAD A GENURACURTALUM IN STANCE. THERE WAS PARESIS ON THE RIGHT LOWER EXTREMITY AND WEAKNESS IN THE LEFT LOWER EXTREMITY. BETWEEN (B)(6) 2011 AND (B)(6) 2012 THE PATIENT PARTICIPATED IN PHYSICAL THERAPY FOR GAIT DEVIATION AND PAIN. ON (B)(6) 2011 THE PATIENT PRESENTED WITH RIGHT NECK, LOW BACK, AND LEG PAIN. ON (B)(6) 2012 THE PATIENT PARTICIPATED IN PHYSICAL THERAPY. ON (B)(6) 2012 THE PATIENT PRESENTED WITH INTERMITTENT LEFT KNEE PAIN. ON (B)(6) 2012 THE PATIENT PRESENTED WITH NO KNEE PAIN BUT WITH A ¿POPPING¿ IN THE KNEE. ON (B)(6) 2012, IN A TELEPHONE ENCOUNTER, THE PATIENT REPORTED THAT THEIR DOCTOR WANTED THEM TO STOP ALL THERAPY.
IT WAS REPORTED THAT ON (B)(6) 2004: THE PATIENT UNDERWENT A CERVICAL FUSION SURGERY WHERE RHBMP-2/ACS WAS IMPLANTED AT C4-6 THROUGH ANTERIOR APPROACH. STRYKER ANTERIOR CERVICAL PLATE, SCREWS WERE ALSO IMPLANTED DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 42340 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M112001ABH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |