INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2013-02037
- Event Type
- Injury
- Date Received
- May 31, 2013
- Report Date
- July 10, 2013
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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)(6) 2007 PATIENT COMPLAINING OF RIGHT UPPER EXTREMITY PAIN/PARAESTHESIAS AND NUMBNESS. PATIENT HAD AN INJURY IN 2004, DEVELOPED SYMPTOMS IN RIGHT UPPER EXTREMITY AND BILATERAL HAND NUMBNESS. MRI SCAN WAS OBTAINED OF THE CERVICAL SPINE THAT SHOWS CERVICAL STENOSIS AT ¿C6-6 AND NEURAL FORAMINAL STENOSIS AT C6-7.¿ PATIENT WAS ADMITTED WITH A DIAGNOSIS OF CERVICAL STENOSIS WITH A HERNIATED DISC. PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C5-C6 WITH STRUCTURAL ALLOGRAFT WITH CAGE. ANTERIOR CERVICAL FORAMINOTOMY C6-C7 WITH PARTIAL C6 AND PARTIAL C7 VERTEBRECTOMY. IT WAS REPORT THAT THERE WAS ¿EXCELLENT DECOMPRESS; A 7MM LORDOTIC SYNTHES ALLOGRAFT PLUS CAGE WAS PLACED IN THE DISK SPACE WITH A PIECE OF BMP WITHIN THE CENTRAL SPACE OF THE BONE GRAFT. (B)(6) 2007 PATIENT WAS SEEN TO CHECK STATUS TWO WEEKS POST CERVICAL DISCECTOMY. PT HAD MINIMAL PAIN AND ¿DIFFICULTY SWALLOWING, AS EXPECTED.¿ (B)(6), 2007 PATIENT WAS SEEN 6 WEEKS POST OP. (PT.) IS DOING ABOUT THE SAME; HAVING A LITTLE LESS PAIN. (PT.) IS TAKING A FEW MORE PAIN PILLS COMPARED TO PREOPERATIVE STATUS. NO COMPLAINTS OF WEAKNESS.¿ (B)(6) 2007 PATIENT WAS SEEN FOR STATUS CHECK 3 MONTHS POST OP. PATIENT COMPLAINED OF ¿NECK PAIN, SCAPULAR BLADE PAIN TO A LOWER EXTENT.¿ (B)(6) 2007 PATIENT WAS SEEN 4.5 MONTHS POST OP. ¿(PT.) IS DOING MODERATELY BETTER. (PT.) STILL HAS SIGNIFICANT NECK PAIN BUT LESS ARM SYMPTOMS. STILL HAVING TINGLING IN RIGHT DISTAL UPPER EXTREMITY.¿ (B)(6) 2007 PATIENT WAS SEEN 6 MONTHS POST OP. IT WAS STATED THAT THE PATIENT ¿DOING ABOUT THE SAME AS PREOPERATIVE STATUS. (PT.) IS NOT SIGNIFICANTLY BETTER, NOT SIGNIFICANTLY WORSE. (PT. ) HAS PAIN IN NECK, RADIATING TO THE SHOULDERS BILATERALLY. ALSO HAS MILD RIGHT UPPER EXTREMITY PAIN. NO COMPLAINTS OF WEAKNESS.¿ (B)(6) 2008 PATIENT WAS SEEN IN THE OFFICE AND COMPLAINED OF ¿PAIN IN NECK AND UPPER EXTREMITY.¿ SURGEON ¿RE-REVIEWED THE MRI SCAN OF THE CERVICAL SPINE WITH (PT.) ONCE AGAIN. (SURGEON) OPINIONS REMAIN UNCHANGED, IN THAT IT LOOKS LIKE THERE IS A GOOD DECOMPRESSION AT BOTH THE C5-6 AND C6-7 LEVELS.¿ (B)(6) 2009 PATIENT WAS SEEN IN THE DOCTOR¿S OFFICE FOR A FOLLOW UP. PT. ¿FEELS THAT HIS RIGHT NECK PAIN AND RIGHT UPPER EXTREMITY PAIN ARE STABLE AND UNCHANGED FOR HIS PREVIOUS EXAM A YEAR AGO. (PT.) CONTINUES TO HAVE RIGHT ELBOW AND WRIST PAIN THAT IS ESSENTIALLY UNCHANGED FROM A YEAR AGO.¿ PATIENT WAS DIAGNOSED AT THIS VISIT WITH ACUTE ONSET OF LEFT NECK PAIN WITH LEFT UPPER EXTREMITY INVOLVEMENT AND CHRONIC RIGHT SIDED NECK PAIN AND INTERMITTENT RIGHT UPPER EXTREMITY PAIN.¿ (B)(6) 2009 PATIENT WAS SEEN IN THE DOCTOR¿S OFFICE FOR A FOLLOW UP. REVIEW OF PATIENT¿S MRI SHOWED ¿EFFUSION AT C5-6. DISC BULGE CENTRAL TO THE LEFT AT C6-7, WHICH IS SEEN MAINLY IN SAGITTAL IMAGES. THERE IS SOME MILD STENOSIS SEEN AT C6-7 ON THE AXIAL IMAGES. NO CHANGES PROXIMAL TO THE C5-6¿ (B)(6) 2012 NECK PAIN, FAILED CTR, WRIST PAIN (B)(6) 2012 MRJ CERVICAL SPINA WITHOUT CONTRAST C4/C5: DISC DESICCATION WITH MILD DISC BULGING PRESENT. C6/C7: SIGNIFICANT DESICCATION WITH MILD DISC BULGING AS OCCURRED AT THIS LEVEL. (B)(6) 2012 PATIENT RECEIVED A C7-TI EPIDURAL STEROID INJECTION TO ADDRESS CERVICALGIA WITH BILATERAL UPPER EXTREMITY RADICULOPATHY. IT IS REPORTED THAT THE PATIENT¿S RADICULOPATHY RUNS TO THE FINGERS BILATERALLY AND TO THE ELBOWS AND FOREARMS BILATERALLY. (B)(6) 2012 IT WAS REPORTED THAT THE PATIENT HAD UNDERWENT A PROCEDURE FOR CERVICAL AND UPPER THORACIC PARASPINOUS AT LEFT AND RIGHT C6, C7 AND T2. (B)(6), 2013 PATIENT REPORTS NECK PAIN AND BACK PAIN AT FOLLOW UP OFFICE VISIT. PATIENT DESCRIBES PAIN AS 6/10; THROBBING, STABBING, HOT BURNING, ACHING, TINGLING, NUMBNESS, DULL AND PINS AND NEEDLES TYPE OF PAIN AND UNABLE TO WORK. (B)(6) 2013 PATIENT REPORTS PAIN IN THE NECK, SHOULDER AND HANDS AT AN OFFICE VISIT. PATIENT DESCRIBES PAIN AS 5- 6/10; THROBBING, STABBING, HOT BURNING, ACHING, TINGLING, NUMBNESS, CRAMPING, WAXES AND WANES, DULL AND PINS AND NEEDLES TYPE OF PAIN AND UNABLE TO WORK. (B)(6) 2013 PATIENT REPORTS PAIN IN THE NECK, JAW, HANDS AND SHOULDER AT AN OFFICE VISIT. PATIENT REPORTS PAIN AS CONSTANT 6/10; THROBBING, STABBING, HOT BURNING, ACHING, TINGLING, NUMBNESS, DULL AND PINS AND NEEDLES TYPE OF PAIN AND UNABLE TO WORK.
ON (B)(6) 2006: PATIENT PRESENTED AT EMERGENCY ROOM WITH CHEST PAINS. IMPRESSION: ACUTE INFERIOR WALL MYOCARDIAL INFARCTION (B)(6) 2007: PER MEDICAL RECORDS, DIAGNOSES:RIGHT UPPER EXTREMITY RADICULOPATHY (C7, POSSIBLE C6), RIGHT C6-7 NEURAL FORAMINAL STENOSIS ,CENTRAL DISC HERNIATION, C5-6 WITH MILD SPINAL STENOSIS ON (B)(6) 2007: PATIENT PRESENTED WITH RIGHT UPPER EXTREMITY PAIN/PARASTHESIAS AND NUMBNESS. PATIENT HAD INJURY IN 2004, DEVELOPED SYMPTOMS IN HIS RIGHT UPPER EXTREMITY AND BILATERAL HAND NUMBNESS. PATIENT COMPLAINS OF PAIN LOCALIZING TO THE RIGHT SIDE OF HIS NECK WITH RADIATION TO THE RIGHT TRAPEZIUS AREA AND MEDIAL BORDER OF THE RIGHT SCAPULA. PRE-OPERATIVE DIAGNOSIS: HERNIATED DISK WITH CENTRAL SPINAL STENOSIS C5-6, FORAMINAL STENOSIS RIGHT C6-7,POST-OPERATIVE DIAGNOSIS: HERNIATED DISK WITH CENTRAL SPINAL STENOSIS C5-6 FORAMINAL STENOSIS RIGHT C6-7 OPERATIONS PERFORMED: ANTERIOR CERVICAL FORAMINOTOMY WITH PARTIAL C6 AND C7 VERTEBRECTOMY ,ANTERIOR CERVICAL DISCECTOMY AND FUSION C5-6,STRUCTURED ALLOGRAFTS WITH CAGE C5-6,APPLICATION OF BMP ANTERIOR SPINAL INSTRUMENTATION,MICROSCOPIC-ASSISTED DISSECTION ,SOMATOSENSORY EVOKED POTENTIALS ON (B)(6) 2007: PER MEDICAL RECORDS, PATIENT IS TWO WEEKS STATUS POST CERVICAL DISCECTOMY AND FUSION. HE HAS MINIMAL PAIN AND IS HAVING DIFFICULTY SWALLOWING, AS EXPECTED. THIS IS BEGINNING TO IMPROVE. ON (B)(6) 2007: PER MEDICAL RECORDS, PATIENT IS DOING ABOUT THE SAME AS HIS PRE-OPERATIVE STATUS. HE IS NOT SIGNIFICANTLY BETTER, NOT SIGNIFICANTLY WORSE. HE HAS PAIN IN HIS NECK, RADIATING TO THE SHOULDERS BILATERALLY. HE ALSO HAS MILD UPPER EXTREMITY PAIN. HE HAS NO COMPLAINTS OF WEAKNESS. ON (B)(6) 2008: IMPRESSION:UNREMARKABLE MAXILLOFACIAL CT IMAGING. SPECIFICALLY, THERE IS NO BONY ABNORMALITY INVOLVING THE MAXILLA OR MANDIBLE. THERE IS NO INFLAMMATORY CHANGE. ON (B)(6) 2008: DIAGNOSES:STATUS POST ANTERIOR CERVICAL FORAMINOTOMY, C6-C7 ,STATUS POST ANTERIOR CERVICAL DISCECTOMY AND FUSION, C5-6,CHRONIC NECK PAIN AND INTERMITTENT RIGHT UPPER EXTREMITY PAIN ON (B)(6) 2009: PER MEDICAL RECORDS, THEY SAW EFFUSION AT C5-6, DISC BULGE CENTRAL TO THE LEFT AT C6-7. THERE IS SOME MILD STENOSIS SEEN AT C6-7 ON THE AXIAL IMAGES. NO CHANGES PROXIMAL TO THE C5-6. ON (B)(6) 2011: FINDINGS-WITHIN THE RIGHT BREAST THERE IS A SOLID MASS AT 10 O'CLOCK. IN THE LEFT BREAST THERE ARE TWO AREAS OF PALPABLE ABNORMALITIES IN WHICH WE SEE NO UNDERLYING MASSES. SONOGRAPHY OF THE RIGHT BREAST DEMONSTRATES A LYMPH NODE AT 10 O'CLOCK. IN THE LEFT BREAST WE FIND NO SONOGRAPHIC ABNORMALITIES. ON (B)(6) 2012: IMPRESSION: POSTOPERATIVE CHANGE INVOLVING C5-C6. DISC DESICCATION AND DISC BULGING AT C4/C5 AND MUCH MORE SEVERLY AT C6-C7. MILD SUBLUXATION SEEN AT C6-C7. ON (B)(6) 2012: PER MEDICAL RECORDS, PATIENT PRESENTED WITH UPPER EXTREMITY RADICULOPATHY WITH CERVICALGIA. HIS RADICULOPATHY RUNS TO THE FINGERS BILATERALLY AND IS IN HIS ELBOWS AND FOREARMS BILATERALLY. ON (B)(6) 2012: PER MEDICAL RECORDS, PATIENT HAS HISTORY OF AN ABNORMAL LYMPHNODE FOUND ON PREVIOUS MAMMOGRAM FOR BREAST ENLARGEMENT. ON (B)(6) 2013: ASSESSMENT- PER MEDICAL RECORDS, ASSESSED DEGENERATIVE DISC DISEASE, CERVICAL SPINE, WITH RADICULOPATHY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241135 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M110609AAD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |