INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2011-01149
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- October 15, 2008
- Report Date
- September 17, 2013
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC.
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
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. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. 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 ON (B)(6) 2008 THE PATIENT UNDERWENT CERVICAL MRI WHICH INDICATED THE FOLLOWING: "C5-C6 -MILD CENTRAL CANAL STENOSIS SECONDARY TO EITHER POSTERIOR DISC/SPUR COMPLEX FORMATION, OR SMALL CENTRAL DISC EXTRUSION. C6-C7 - MINIMAL POSTERIOR DISC/SPUR COMPLEX FORMATION WITHOUT SIGNIFICANT CENTRAL CANAL STENOSIS. MILD BILATERAL FORAMINAL STENOSIS SECONDARY TO UNCOVERTEBRAL JOINT HYPERTROPHY." ON (B)(6) 2008 THE PATIENT PRESENTED TO THE CLINIC WITH "2 LEVEL CERVICAL DISC AND SPONDYLYTIC DISEASE WITH DEMONSTRABLE WEAKNESS IN THE C6-7 DISTRIBUTION. RADIOGRAPHS SHOWED LEFT-SIDED C6-7 DISC AND SPUR COMPLEX WITH MARKED ATTENUATION AT THE FORAMEN AND A BROAD-BASED DISC SPUR COMPLEX AT THE C5-6 LEVEL." PER THE CLINIC RECORD, "SHE HAS BEEN AGGRESSIVELY MANAGED NON-SURGICALLY AND CONTINUES TO HAVE PAIN AND ACTIVITY INTOLERANCE. I HAVE OFFERED HER ACDF, AND... SHE WOULD LIKE TO PROCEED". ON (B)(6) 2008 THE PATIENT UNDERWENT ACDF USING MEDTRONIC ATLANTIS PLATE AND SCREWS, INFUSE X-SMALL KIT, AND NON-MEDTRONIC PEEK INTERBODY CAGE TO TREAT CERVICAL SPONDYLOSIS AND MYELORADICULOPATHY. PATIENT TOLERATED THE PROCEDURE WELL WITH NO COMPLICATIONS. ON (B)(6) 2008 THE PATIENT PRESENTED TO THE CLINIC FOR FOLLOW-UP OF ACDF. PER THE CLINIC RECORDS, "RETURNS TODAY DOING VERY WELL. HER STRENGTH HAS SIGNIFICANTLY IMPROVED AND SHE IS DELIGHTED WITH HER PROGRESS". ON (B)(6) 2009 THE PATIENT PRESENTED TO THE CLINIC FOR FOLLOW-UP OF ACDF. PER THE CLINIC RECORDS, THE PATIENT "RETURNS TODAY OVERALL DOING QUITE WELL. SHE HAS SOME INTERMITTENT CERVICALGIA, BUT HAS NO MYELORADICULAR SYMPTOMS. SHE HAS RECEIVED A SOLID RADIOGRAPHIC ARTHRODESIS." ON (B)(6) 2010 THE PATIENT UNDERWENT A CERVICAL MRI WHICH INDICATED THE FOLLOWING: "C3-C4 -SMALL DISC-SPUR COMPLEX. MINOR CANAL NARROWING. MILD LEFT FORAMINAL STENOSIS FROM LEFT UNCINATE AND FACET HYPERTROPHY. C4-C5 - BROAD DISC-SPUR COMPLEX. MILD CANAL STENOSIS. RIGHT FORAMINAL STENOSIS FROM UNCINATE AND FACET HYPERTROPHY. C5-C7 - POSTOP SURGICAL CHANGES WITH HARDWARE NOTED. UNCINATE HYPERTROPHY RESULTS IN MINIMAL FORAMINAL NARROWING AT C6-C7." ON (B)(6) 2010 THE PATIENT UNDERWENT A CERVICAL X-RAY WHICH DEMONSTRATED THE FOLLOWING: " A SMALL AMOUNT OF LIGAMENTOUS CALCIFICATION HAS DEVELOPED ANTERIOR TO C4-C5 DISC SPACE. NO LYTIC OR BLASTIC LESIONS ARE SEEN. FACET ARTHRITIC CHANGES ARE SEEN FROM C3 - C5. OPINION: ANTERIOR CERVICAL FUSION FROM C5 - C7. NO ACUTE OSSEOUS ABNORMALITY IDENTIFIED AS DETAILED ABOVE". ON (B)(6) 2010 THE PATIENT PRESENTED TO THE CLINIC WITH CONTINUED CERVICALGIA AND A FOCUS OF NECK PAIN IN THE RIGHT CERVICAL PARASPINAL REGION. PER THE CLINIC RECORDS, "THERE IS NO DEMONSTRABLE NEUROLOGIC DEFICIT, SPACICITY, OR MYELOPATHY. WE HAVE REVIEWED PLAIN RADIOGRAPHY AND AN MRI WHICH DEMONSTRATE A SOLID FUSION AT C5-7 WITH NO TRANSITION SEGMENT SYNDROME AND A WELL-PRESERVED CERVICAL LORDOSIS. I BELIEVE HER PAIN IS MYOFASCIAL, BOTH FROM FOCAL IRRITATION AND BIOMECHANICAL ALTERATION FROM HER PREVIOUS BREAST SURGERIES AND TRAM FLAP." ON (B)(6) 2011 THE PATIENT UNDERWENT A CERVICAL MRI WHICH INDICATED THE FOLLOWING: "FINDINGS: CHANGES OF ACDF ARE SEEN FROM C5 - C7, AND CONSISTS OF ARTIFACT RELATED TO CERVICAL VERTEBRAL BODY SCREWS AT C5, C6, AND C7, AS WELL AS GRAFT MATERIAL IN THE INTERVENING DISC SPACE IS NEW. NO EVIDENCE FOR DISPLACEMENT OF THE GRAFT AND/OR SURGICAL HARDWARE MATERIAL. ANATOMIC ALIGNMENT AND VERTEBRAL HEIGHT MAINTENANCE THROUGH THE CERVICAL SURGICAL LEVEL." C2-C3 -THERE IS LEFT-SIDE PREDOMINANT NEURAL FORAMEN STENOSIS SECONDARY TO FACET DISEASE. C3-C4 - THERE IS LEFT-SIDE NEURAL FORAMEN STENOSIS SECONDARY TO FACET DEGENERATIVE CHANGE. C4-C5 - THERE IS BROAD DISC-OSTEOPHYTE COMPLEX, ECCENTRIC TO RIGHT OF MIDLINE, MILD TO MODERATE NEURAL FORAMINAL NARROWING. C5-C6 - NO APPRECIABLE CENTRAL CANAL OR NEURAL FORAMEN STENOSIS. C6-C7 - SHOWS ARTIFACTS... CENTRAL CANAL STENOSIS OR CORD COMPRESSION. IMPRESSION: 1. SURGICAL CHANGES FROM ACDF C5 - C7 UNCOMPLICATED. 2. LEFT SIDE NEURAL FORAMINAL STENOSIS C2-3, C3-4 SECONDARY TO FACET DISEASE 3. MILD BROAD DISC OSTEOPHYTE DISEASE C4-5 CAUSING RIGHT SIDED NEURAL FORAMINAL STENOSIS. ON (B)(6) 2011 AN ADDENDUM REPORT WAS DICTATED FOR THE CERVICAL MRI COMPLETED ON (B)(6) 2011: DIRECT COMPARISON IS MADE WITH PRIOR EXAMINATIONS DONE (B)(6) 2010 AND (B)(6) 2008. IN COMPARISON WITH PRIOR EXAM THERE IS NO SUBSTANTIVE CHANGE IN THE RIGHT SIDED NEURAL FORAMINAL STENOSIS AT C4-5, C6-7, OR IN THE NEURAL FORAMINAL STENOSIS ON THE LEFT SIDE AT C3-4 AND C4-5 MORE MINIMALLY. DESPITE ARTIFACT AT C6-7, THERE DOES APPEAR THAT THERE IS SOME SPUR PRESENT, AND SOME NEURAL FORAMINAL ENCROACHMENT AS DESCRIBED ON PRIOR REPORT, (B)(6) 2010, WHICH IS STABLE. THERE HAS NOT BEEN APPRECIABLE INTERVAL CHANGE BETWEEN THE MOST RECENT EVALUATION (B)(6) 2010, AND THE CURRENT STUDY. IN REVIEW OF PRIOR EXAM INDICATION OF NEURAL FORAMINAL NARROWING AT C6-7 ON EACH SIDE, WHICH I BELIEVE IS PRESENT ALTHOUGH LESS DELINEATED TODAY... DUE TO ARTIFACT. THIS IS MARGINALLY WORSE ON THE RIGHT SIDE THAN ON THE LEFT SIDE. THE EXAM SHOWS STABILITY OF THESE CHANGES AS WELL AS NEURAL FORAMINAL NARROWING AT RIGHT C4-5, AND LEFT C2-3, AND C3-4. THE EXAMS DO NOT SHOW A SUBSTANTIVE DIFFERENCE. THE AVAILABLE IMAGES FROM 2008 WERE PRIOR TO SURGICAL INTERVENTION, AND SHOW WHAT APPEAR TO BE BROAD DISC-OSTEOPHYTE COMPLEXES AT C5-6 AND C6-7, WHICH ARE NOT APPARENT ON THE CURRENT EXAM. ON (B)(6) 2011 THE PATIENT PRESENTED TO THE CLINIC OF DR. STEPHEN WRAY FOR FOLLOW-UP EVALUATION. PER THE CLINIC RECORDS, "MS. (B)(6) RETURNS TODAY WITH VOLUMINOUS ON-LINE RESEARCH REGARDING ARACHNOIDITIS. SHE DESCRIBES DYSESTHESIAS AND PARESTHESIAS THROUGHOUT HER BODY IN A NON-DERMATOMAL DISTRIBUTION. SHE STATES SHE IS UNSTEADY WITH GAIT. SHE HAS DIFFICULTY ASCENDING STAIRS AND SHE HAS FALLEN. SHE ALSO HAS PARESTHESIAS IN HER ARMS AND LEGS." A CERVICAL SPINE MRI INDICATED "MILD TO MODERATE TRANSITION SEGMENT SYNDROME AT C4-5 WITH SLIGHT, 2MM ANTEROLISTHESIS WITH SOME UNCOVERTEBRAL HYPERTROPHY AND SOME SPONDYLITIC CHANGE. THERE IS NO SIGNIFICANT FORAMINAL NARROWING AND NO DEMONSTRABLE WEAKNESS." ON (B)(6) 2011 THE PATIENT UNDERWENT A THORACIC MRI WHICH DEMONSTRATED THE FOLLOWING: MILD DISC SPACE NARROWING AND DISC DESICCATION OF SEVERAL UPPER THORACIC DISC LEVELS INDICATING MILD DEGENERATIVE DISC CHANGES. CANAL AND NEURAL FORAMINA REMAIN PATENT. IMPRESSION: MILD DEGENERATIVE DISC CHANGES AS DESCRIBED ABOVE WITHOUT CHANGE (COMPARISON WITH MRI DATED (B)(6) 1997). ON (B)(6) 2011 THE PATIENT UNDERWENT A LUMBAR MRI WHICH DEMONSTRATED THE FOLLOWING: L4-L5 -SLIGHT DISC DESICCATION WITHOUT LOSS OF DISC HEIGHT INDICATES MINOR DEGENERATIVE DISC CHANGES. MINOR DISC BULGE AND MINOR FACET CHANGES CAUSE SLIGHT CANAL AND NEURAL FORAMINAL NARROWING. ON (B)(6) 2011 THE PATIENT COMPLETED A MEDWATCH REPORT WHICH WAS SUBMITTED TO THE FDA. POSTOPERATIVELY, THE PATIENT CLAIMS TO HAVE "EXPERIENCED SEVERE AND PROLONGED AUTOIMMUNE SYMPTOMS". PATIENT INDICATED THAT IMMEDIATELY POSTOPERATIVELY SHE HAD EXTREME DIFFICULTY SPEAKING ("JUST A LITTLE WHISPER") AND BREATHING, AND WAS GASPING BETWEEN WORDS. SHE STATES SHE COULD NOT SWALLOW. PATIENT FURTHER ALLEGES THAT SINCE THE SURGERY HER "AUTOIMMUNE SYSTEMS IN BODY HAVE NOT BEEN RIGHT". ADDITIONALLY, SHE REPORTS, "I HAVE HAD HEAVY SCARRING (ADHESIONS)", BLOOD WORK SHOWS PROGRESSION INCREASE IN RF", "BONE SPURS GREW IN NUMEROUS AREAS". THE REPORT CONTINUES, " I HAVE HAD SEVERE UPPER BACK SPASMS (THROWING UP FROM THE PAIN MANY TIMES. HAD TO CALL AMBULANCE), "ADHESIONS AND HEAVY, DENSE SCARRING GREW IN UNRELATED AREAS (IN ABDOMINAL AREA FROM TRAM FLAP REMOVAL SCARRING IS SO THICK IT LIMITS MY ENTIRE MOVEMENT OF MY BODY TRUNK)", "EYESIGHT HAS DECLINED/BLURRY", SEVERE PAIN IN UPPER BACK, NECK, CAUSING ARMS AND HANDS TO WEAKEN", "WEAK/WOBBLY LEGS ALSO AFFECTED", "CONSISTENT PAIN THAT CONTINUED TO WORSEN - SEVERE PAIN-FEELING OF CONSTRICTED BODY FLOOD." "TEMPERATURE SENSITIVITY", "WEAKNESS/ SHAKY", "INCREASE IN BLOOD PRESSURE", "HIGHER THAN NORMAL RH BLOOD WORK THAN PRIOR TO SURGERY NORMAL", "OTHER NEGATIVE EFFECTS OCCURRED". PATIENT RELATES SYMPTOMS TO INFUSE AS FOLLOWS: "RIGHT AWAY I HAD SEVERE SIDE EFFECTS FROM INFUSE-BMP-2 FROM MEDTRONIC. YEARS LATER, I STILL HAVE THESE SEVERE SIDE EFFECTS. UP UNTIL SENATE INVESTIGATION WAS REPORTED, I DID NOT KNOW WHAT WAS CAUSING THE PROBLEMS AND PAIN. I WAS NEVER TOLD ANY POSSIBLE ADVERSE REACTIONS NOR THAT ANY COMPLICATIONS HAD EVER BEEN REPORTED". ON (B)(6) 2011 THE PATIENT PRESENTED TO THE CLINIC OF DR. (B)(6) WITH MULTIPLE COMPLAINTS INCLUDING CHIEF COMPLAINT OF NECK PAIN WITH BILATERAL BURNING DYSESTHESIAS IN HER ARMS. PATIENT ALSO INDICATED PAIN RADIATING DOWN ACROSS HER ABDOMEN. PER THE CLINICAL RECORDS, PATIENT HAS A "COMPLEX HISTORY" INCLUDING BRCA1 GENE FOR INCREASED RISK OF BREAST CANCER, LONG-STANDING BACK PAIN, WHICH SHE RELATES TO AN EPIDURAL INJECTION DURING CHILDBIRTH IN 1997, AND LOWER EXTREMITY POSSIBLE RADICULAR COMPLAINTS. ALSO NOTED IS A LONG HISTORY OF NECK PAIN RADIATING INTO BILATERAL TRAPEZIUS, DOWN BOTH ARMS INTO DIGITS 1 - 3. PATIENT RELATED THAT HER ACDF IN 2008 WITH PEEK CAGE AND INFUSE "ACTUALLY WORSENED HER NECK AND BILATERAL ARM PAIN". X-RAYS OF THE CERVICAL SPINE APPEARS TO DEMONSTRATE.. A VERY MATURE HEALING OF THE POSTERIOR INTERBODY SPACE WITH THE PEEK CAGES, BUT WITHOUT A GREAT DEAL OF BONY IN-GROWTH WITHIN THEM. "THERE IS A FIRM AREA ON PALPATION IN THE AREA, WHICH INDUCES SOME DISCOMFORT IN THE PATIENT, BUT ITS RELATIONSHIP TO THE BMP2 USE, AND TO HER PRESENT COMPLAINT, IS UNCLEAR TO ME AT THIS TIME. IN ADDRESSING HER SPINE OR UPPER EXTREMITY COMPLAINTS, THE PROVIDED ED MRI SHOWS NO OBVIOUS PROBLEMATIC NERVE COMPRESSIONS, BUT SHE HAD BECOME AWARE OF SOME OF THE RECENT MEDIA COVERAGE OF A QUESTION OF NEURO-INFLAMMATION FROM BMP2. I DID TELL HER THAT IT WAS CERTAINLY CONCEIVABLE THAT THIS MIGHT BE A FACTOR. I AM CURIOUS ABOUT ANY POSSIBLE OSSIFICATION AREAS WITHIN THE CANAL, PERHAPS NOT WELL SEEN BY THE MRI." A CERVICAL CAT SCAN WAS RECOMMENDED. ON (B)(6) 2011 THE PATIENT UNDERWENT A CERVICAL CT SCAN WHICH DEMONSTRATED THE FOLLOWING: "THERE IS MILD ANTERIOR OSTEOPHYTOSIS AT C4-5 AND C7-T1. THERE IS OSTEOPHYTIC CHANGE CONTRIBUTING TO BILATERAL NEURAL FORAMINAL NARROWING AT C6-7 AND MILD FACET DEGENERATIVE CHANGES ON THE LEFT AT C3-4. ON (B)(6) 2011 THE PATIENT UNDERWENT A CT OF THE ABDOMEN AND PELVIS WHICH RESULTED IN THE FOLLOWING IMPRESSION: ABNORMAL, THICK-WALLED FLUID COLLECTION WITHIN THE DEEP SUBCUTANEOUS FAT ANTERIOR TO THE ANTERIOR ABDOMINAL WALL. QUESTION WHETHER OR NOT THIS COULD BE POSTOPERATIVE. CANNOT EXCLUDE AN ABCESS. ON (B)(6) 2011 THE PATIENT UNDERWENT AN ABDOMINAL ULTRASOUND WHICH DEMONSTRATED THE FOLLOWING: HISTORY: (B)(6) FEMALE WITH HISTORY OF ABDOMINAL WALL SEROMA. ON (B)(6) 2011, THIS WAS ASPIRATED. THERE IS A HISTORY OF A TRAM FLAP RECONSTRUCTION SURGERY. ULTRASOUND OF THE MID-RIGHT ABDOMINAL WALL DEMONSTRATES AN OVAL FLUID COLLECTION. IMPRESSION: APPARENT REACCUMULATION OF ABDOMINAL WALL SEROMA. ON (B)(6) 2012 THE PATIENT UNDERWENT PET/CT IMAGING FROM BASE OF SKULL TO MID-THIGH. INDICATION: BREAST CANCER STATUS POST BILATERAL MASTECTOMIES WITH TRAM FLAP RECONSTRUCTION, SUBSEQUENT REVISION WITH BREAST IMPLANTS AND REMOVAL OF IMPLANTS. NO HISTORY OF CHEMOTHERAPY OR RADIATION. NOW WITH COMPLAINTS OF ABDOMINAL TIGHTNESS AND TENDERNESS AND POSSIBLE ABDOMINAL MASS. REPORTED CHRONIC ABDOMINAL WALL SEROMA. IN THE CHEST THERE ARE NO HYPERMETABOLIC LESIONS. THERE IS A CALCIFIED LEFT UPPER LOBE GRANULOMA. A CALCIFIED LEFT HILAR LYMPH NODE IS CONSISTENT WITH REMOTE GRANULOMATOUS DISEASE. IN THE ABDOMEN AND PELVIS THERE IS NO DISCRETE MASS WITHIN THE ABDOMINAL CAVITY. THERE IS A 6MM WELL CIRCUMSCRIBED SOFT TISSUE NODULE AT THE ANTERIOR PERITONEAL SURFACE. THERE IS PUNCTATE CALCIFICATION OF THE SPLEEN CONSISTENT WITH GRANULOMATOUS DISEASE. WITHIN THE SUBCUTANEOUS FAT OF THE ANTERIOR ABDOMINAL WALL EXTENDING INTO THE ANTERIOR PELVIC WALL, THERE IS A SUBCUTANEOUS FLUID COLLECTION CORRESPONDING WITH KNOWN CHRONIC SEROMA. IN THE OSSEOUS STRUCTURES THERE IS MILD FOCAL ACTIVITY OVERLYING THE LEFT GREATER TROCHANTER CORRESPONDING TO THE BURSA. A SEPARATE RADIOGRAPHIC INTERPRETATION IS PROVIDED BY "USRADREVIEW.COM" AND ADDS THE FOLLOWING: LYTIC LESION AT THE LEFT LAMINA OF C3, OR POSSIBLY C4, WITH QUESTIONABLE FRACTURE. MILD INCREASED METABOLIC ACTIVITY IS SEEN AT THE LEFT LATERAL POSTERIOR ELEMENTS OF THIS LEVEL WHICH MAY BE ARISING FROM THE ADJACENT ARTHROPATHY VERSUS THE DESCRIBED LYTIC LESION.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A MULTI-LEVEL CERVICAL FUSION PROCEDURE USING RHBMP-2/ACS AND A TITANIUM CAGE. IMMEDIATELY POST-OP THE PATIENT HAD SWALLOWING AND BREATHING DIFFICULTIES. REPORTEDLY, THE PATIENT NOW HAS "A HOST OF COMPLICATIONS" INCLUDING AUTOIMMUNE RESPONSE, SCARRING TISSUE, ECTOPIC BONE GROWTH, STENOSIS AND SPURS IN THE SPINE, AND "OSTEOLYTES." THE PATIENT HAS GONE ADDITIONAL SURGERIES AS A RESULT OF THE COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention |