INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2014-00171
- Event Type
- Injury
- Date Received
- January 17, 2014
- Report Date
- January 8, 2016
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- ATTORNEY
Narratives
(B)(4).
(B)(6). 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)(6). (B)(4).
(B)(4).
IT WAS REPORTED THAT ON : (B)(6) 2014 THE PATIENT UNDERWENT MRI OF THE LUMBAR SPINE. IMPRESSIONS: MULTILEVEL GENERALIZED DISK BULGES WITH FACET HYPERTROPHY AT L3-4 AND L4-5; MILD CANAL STENOSIS AT L3-4; POSTOPERATIVE CHANGES AT L4-5 WITH MILD CANAL STENOSIS; POSTOPERATIVE CHANGES AT L5-S1 WITH MILD EPIDURAL FIBROSIS ON THE LEFT; MILD ENLARGEMENT OF THE COMMON BILE DUCT; PROBABLE BILATERAL RENAL CYSTS, THE LARGEST MEASURING 2.4CM IN DIAMETER THE RIGHT KIDNEY. THE [PATIENT ALSO UNDERWENT MRI OF THE THORACIC SPINE. IMPRESSIONS: SMALL DISC PROTRUSION ON THE RIGHT AT T3-4; FACET HYPERTROPHY AND MILD CANAL STENOSIS AT T12-L1. THE PATIENT ALSO UNDERWENT MRI OF THE CERVICAL SPINE. IMPRESSIONS: MULTILEVEL MILD GENERALIZED DISC BULGES. ON (B)(6) 2014 THE PATIENT UNDERWENT XRAYS OF THE LEFT HIP. IMPRESSIONS: NEGATIVE LEFT HIP; APPARENT DEGENERATIVE CHANGES IN THE VISUALIZED LOWER LUMBAR SPINE. THIS WOULD BE BETTER EVALUATED WITH LUMBAR SPINE SERIES. ON (B)(6) 2015 THE PATIENT UNDERWENT XRAYS OF THE CHEST. IMPRESSIONS: NO ACUTE ABNORMALITY. THE PATIENT UNDERWENT XRAYS OF THE LUMBAR SPINE. IMPRESSIONS: DEGENERATIVE CHANGES WITHOUT EVIDENCE OF ACUTE ABNORMALITY. ON (B)(6) 2015 THE PATIENT UNDERWENT CT SCAN OF THE CHEST. IMPRESSIONS: SMALL NODULE IN THE RIGHT LUNG APEX, MOST LIKELY BENIGN. GIVEN THE HISTORY OF SMOKING, A FOLLOWUP CHEST CT COULD BE OBTAINED IN 6MONTHS TO ONE YEAR TO ENSURE STABILITY; OTHERWISE UNREMARKABLE NON CONTRAST CT OF THE CHEST. THE PATIENT ALSO UNDERWENT MRI OF THE LUMBAR SPINE. IMPRESSIONS: POSTPOERATIVE CHANGES AT L4-5 WITH MILD CANAL STENOSIS, UNCHANGED ; POSTOPERATIVE CHANGES AT L5-S1 WITH MODERATE EPIDURAL FIBROSIS ON THE LEFT, UNCHANGED; MILD LUMBAR ARACHNOIDITIS AT THE L5 LEVEL, UNCHANGED; DENERVATION STROPHY OF THE POSTERIOR PARASPINAL MUSCLES WITH PERSISTENT EDEMA AT L5 THROUGH S2 BILATERALLY, UNCHANGED; BILATERAL RENAL CYSTS, UNCHANGED. THE PATIENT ALSO UNDERWENT MRI OF THE THORACIC SPINE. IMPRESSIONS: POSSIBLE PARS BREAK ON THE RIGHT AT T11-12. ON (B)(6) 2011: PATIENT UNDERWENT HARDWARE REMOVAL L5-S1, EXPLORATION AND FUSION L5-S1, DECORTICATION AND FUSION L5-S1, FOR A PRE-OP DIAGNOSIS OF RETAINED HARDWARE L5-S1. PER-OP NOTES: INCISION WAS CARRIED DOWN, THE HARDWARE WAS EXPOSED, SET SCREWS WERE REMOVED WHICH ALLOWED REMOVAL OF SPINAL RODS. A STANDARD SCREWDRIVER WAS USED TO REMOVE ALL 4 PEDICLE SCREWS. AFTER THIS THE PATIENT'S WOUND WAS EXPLORED. IT SEEMED SHE HAD A THIN FUSION AT L5-S1. AFTER FORAMINOTOMY AND DECOMPRESSION RHBMP-2 WITH BONE GRAFT WAS PLACED INTO THE LATERAL GUTTERS AND THE FASCIA WAS THEN CLOSED IN INTERRUPTED FASHION WITH VICRYL. NO COMPLICATIONS WERE REPORTED DURING THE PROCEDURE. ON (B)(6) 2011, PATIENT UNDERWENT X-RAY OF LUMBAR SPINE. IMPRESSION: POSTOP CHANGES WITH APPARENT REMOVAL OF THE ORTHOPEDIC HARDWARE. NO RETAINED FRAGMENTS ARE IDENTIFIED. ON (B)(6) 2011, PATIENT PRESENTED FOR OFFICE VISIT. PATIENT REPORTED LEFT LEG PAIN.
IT WAS REPORTED THAT ON (B)(6) 2010: PATIENT WAS INVOLVED IN MOTOR VEHICLE ACCIDENT AND, SINCE THEN, SHE HAD BEEN HAVING SOME INCREASED LOW BACK PAIN AND DISCOMFORT. ON (B)(6) 2010: PATIENT PRESENTED FOR FOLLOW UP. ON (B)(6) 2010: PATIENT PRESENTED FOR POST-OP FOLLOW UP. PATIENT WAS HAVING SOME TINGLING INVOLVING HER LOWER EXTREMITIES. AP AND LATERAL SPINE FILMS SHOWED THE RODS IN GOOD POSITION AND THE BONE GRAFT IS IN GOOD ABUNDANCE IN THE LATERAL GUTTERS. ON (B)(6) 2010: PATIENT PRESENTED WITH COMPLAINS OF A LOT OF DECREASED SENSATION INVOLVING THE RIGHT BUTTOCKS AND THE LATERAL ASPECT OF THE RIGHT HIP AREA. SHE IS VERY TENDER WHERE THE SHORT EXTERNAL ROTATORS INSERT INTO THE POSTERIOR PART OF HER GREATER TROCHANTER. HER AP AND LATERAL X-RAYS SHOWED THE RODS AND SCREWS ARE IN GOOD POSITION AT 5-1. NO RADIOLUCENCY ABOUT THE SCREWS. ON (B)(6) 2010: PATIENT PRESENTED FOR FOLLOW UP AND WAS VERY TENDER OVER THE GREATER TROCHANTER. THE INJECTION DID NOT HELP. AP AND LATERAL X-RAYS TODAY SHOWED EVERYTHING TO BE IN GOOD POSITION. SHE APPEARS TO HAVE A SOLID ARTHRODESIS. ON (B)(6) 2011: PATIENT PRESENTED WITH NUMBNESS AND TINGLING IN HER LEGS. ON (B)(6) 2011: PATIENT PRESENTED WITH PAIN IN HER LEFT LEG. X-RAY SHOWED SCREWS ARE ALL STIMULATED, 20 OR ABOVE. IT LOOKS LIKE SHE HAS BONE AROUND THE SCREWS EXCEPT FOR PROBABLY ONE LITTLE CUT. ON (B)(6) 2011: PATIENT UNDERWENT HARDWARE REMOVAL L5-S1, EXPLORATION AND FUSION L5-S1, DECORTICATION AND FUSION L5-S1. ON (B)(6) 2011: PATIENT PRESENTED FOR FOLLOW UP. SHE HAD REMOVAL OF INSTRUMENTATION AND REINFORCEMENT OF HER BONE FUSION WITH RE-GRAFTING SHE WAS HAVING A FAIR AMOUNT OF MUSCLE SORENESS IN THE LOWER LUMBAR SPINE AREA. AP AND LATERAL X-RAYS SHOWED THE BONE GRAFT TO BE IN GOOD POSITION. ON (B)(6) 2013, THE PATIENT PRESENTED FOR PATIENT EDUCATION REGARDING BACK PAIN; PARESTHESIA ON (B)(6) 2013, THE PATIENT UNDERWENT CT SCAN OF HEAD AND CHEST. ON (B)(6) 2013, THE PATIENT VISITED THE FACILITY AND UNDERWENT PHYSICAL EXAMINATIONS.
(B)(6). THE SURGICAL APPROACH USED: POSTEROLATERAL FUSION PATIENT REPORTED THAT WHILE WALKING SOMETHING WOULD POP IN HER BACK AND SHE EXPERIENCED CHRONIC BACK PAIN WHICH LED HER TO UNDERGO RHBMP-2/ACS TREATMENT. ON (B)(6) 2010: PATIENT UNDERWENT RHBMP-2/ACS SURGERY AND WAS ALSO IMPLANTED WITH LEGACY SCREW SYSTEM. ON (B)(6) 2011: PATIENT UNDERWENT FOR ANOTHER POSTEROLATERAL FUSION SURGERY WITH COMBINATION OF RHBMP-2/ACS AND BIONE GRAFT USED IN THE LATERAL GUTTERS. POST-OP RHBMP-2/ACS TREATMENT, PATIENT ALLEGED INJURIES INCLUDING, BUT ARE NOT LIMITED TO SEVERE NERVE PAIN AND BAD ACHES. PATIENT HAD TO WALK SLIGHTLY BENT OVER AS IT IS TOO PAINFUL TO WALK STRAIGHT. PATIENT REPORTED THAT HER PAIN WAS NEVER GONE AFTER SURGERY. PATIENT'S BACK PAIN AND OTHER SYMPTOMS BEGAN TO INCREASE IN (B)(6) 2011. PATIENT ALLEGED THAT SHE IS NO LONGER ABLE TO WALK NORMALLY. IN YEAR 2009-13, ON UNKNOWN DATES PATIENT PRESENTED WITH DIAGNOSIS OF BACK PAIN. FOR WHICH PATIENT ALSO UNDERWENT FOR IMAGING STUDIES. ON (B)(6) 2011: THE PATIENT UNDERWENT RE-DO OF LEFT L5-S1 LUMBAR LAMINOTOMIES, FORAMINOTOMIES AND MEDIAL FACETECTOMIES; L5-S1 HARDWARE REMOVAL; EXPLORATION AND FUSION L5-S1. IN 2012 OR 2013, ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR GALLBLADDER REMOVAL. ON AN UNKNOWN DATE, PATIENT GOT HER RIGHT BENIGN BREAST MASS REMOVED. (B)(6) 2011 THE PATIENT UNDERWENT X-RAYS OF THE LEFT HIP DUE TO PAIN STATUS POST FALL. IMPRESSION: NO FRACTURE OR DISLOCATION. ALSO THE PATIENT UNDERWENT LUMBAR SPINE SERIES. THE PATIENT UNDERWENT CT OF THE LUMBAR SPINE WITH OUT CONTRAST DUE TO LOW BACK PAIN RADIATING TO LEFT HIP. (B)(6) 2013 THE PATIENT PRESENTED WITH THE COMPLAINT OF INTERMITTENT CHEST WALL PAIN AND BURNING SENSATION IN BACK. THE PAIN WAS LOCATED ON THE LOWER STERNAL SIDE AND WAS DESCRIBED AS CRUSHING. THE PATIENT UNDERWENT X-RAYS OF THE CHEST DUE TO COUGH AND CHEST PAIN. (B)(6) 2014 THE PATIENT UNDERWENT SCREENING MAMMOGRAM. (B)(6) 2014 THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO CHEST PAIN. THE PATIENT PRESENTED WITH SHAKING, AND COMPLAINED OF NUMBNESS TO FACE AND BILATERAL HANDS. EKG RESULTS WERE NODAL AND IT SHOWED NO ACUTE CHANGES. (B)(6) 2006: THE PATIENT PRESENTED WITH PRIMARY DIAGNOSIS OF BILATERAL DORSAL GANGLION CYST. THE PATIENT UNDERWENT X-RAY OF LATERAL WRIST LUNATE BONE CYST. (B)(6) 2006: THE PATIENT UNDERWENT MRI OF RIGHT AND LEFT WRIST. (B)(6) 2006: THE PATIENT PRESENTED WITH COMPLAINT OF BILATERAL DORSAL WRIST GANGLION. THE PATIENTMRI REPORTS WERE REVIEWED. (B)(6) 2006: THE PATIENT PRESENTED WITH PRE-OPERATIVE DIAGNOSIS OF DORSAL GANGLION CYST RIGHT WRIST. THE PATIENT UNDERWENT EXCISION OF DORSAL GANGLION CYST OF RIGHT WRIST. (B)(6) 2006: THE PATIENT PRESENTED FOR FOLLOW-UP 17 DAYS POST-OP. STATUS POST GANGLION RIGHT WRIST ON (B)(6) 2006. (B)(6) 2006: THE PATIENT PRESENTED WITH PRE-OPERATIVE DIAGNOSIS OF DORSAL GANGLION CYST OF LEFT WRIST. THE PATIENT UNDERWENT LEFT WRIST EXCISION OF DORSAL GANGLION CYST.
IT WAS REPORTED THAT ON, (B)(6) 2013 PATIENT PRESENTED DUE TO PERSISTENT PAIN. IMPRESSION: FAILED LOW BACK PAIN SYNDROME WITH PERSISTENT LOW BACK PAIN AND NEUROPATHIC SYMPTOMS INTO BOTH LEGS. (B)(6) 2014 THE PATIENT UNDERWENT MRI OF THE CERVICAL SPINE. IMPRESSIONS: MULTILEVEL MILD GENERALIZED DISK BULGES. (B)(6) 2014 CT RENALS W/WO ULTRAVIST 240 100ML. IMPRESSION: 1. RIGHT RENAL NONOBSTRUCTING CALCULUS IN THE LOWER POLE. 2. BILATERAL RENAL CYSTS. 3. 2.4 CM LEFT OVARIAN CYST. 4. STATUS POST CHOLECYSTECTOMY. (B)(6) 2014 THE PATIENT UNDERWENT MRI OF THE LUMBAR SPINE. IMPRESSIONS: L4-S1 LAMINECTOMIES, INCOMPLETELY EVALUATED WITHOUT CONTRAST ADMINISTRATION BUT NO RECURRENTRESIDUAL DISC MATERIAL. MILD ARACHNOIDITIS. BILATERAL L5-S1 DORSOLATERAL FUSION, SOLID. MULTILEVEL S ECONDARY DISC AND FACET CHANGE, UNCHANGED. NO DISC HERNIATION, CANAL OR FORAMINAL STENOSIS AT ANY OTHER LEVEL.
IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT A POSTEROLATERAL LUMBAR FUSION SURGERY AT L5-S1, USING A COMBINATION OF AUTOGRAFT AND RHBMP-2/ACS THAT WAS PLACED IN THE POSTERIOR LATERAL GUTTERS. ON (B)(6) 2010, THE PATIENT COMPLAINED OF PAIN RADIATING DOWN HER LEGS, WORSENING SINCE HER SURGERY. HER SURGEON ORDERED A CT SCAN. HER SURGEON NOTED A RE-EXPLORATION MAY BE NECESSARY AT A LATER DATE. THE PATIENT CONTINUED TO FOLLOW UP WITH HER SURGEONS AS INSTRUCTED AND CONTINUED TO COMPLAIN OF PAIN. ON (B)(6) 2010, THE PATIENT UNDERWENT A CT MYELOGRAM OF HER LUMBAR SPINE TO EVALUATE HER COMPLAINTS OF PAIN. ON (B)(6) 2011, THE PATIENT UNDERWENT A CT SCAN OF HER LUMBAR SPINE WHICH SHOWED ECTOPIC BONE GROWTH INTO AND AROUND THE THECAL SAC. ON (B)(6) 2011, THE PATIENT UNDERWENT A REVISION SURGERY WHERE THE HARDWARE AT L5-S1 WAS REMOVED, AND AFTER NEUROSURGERY WAS FINISHED WITH THEIR DECOMPRESSION, RHBMP-2/ACS WAS AGAIN PLACED INTO THE LATERAL GUTTERS AT L5-S1. POST-OPERATIVELY, THE PATIENT CONTINUED TO COMPLAIN OF LOWER BACK PAIN RADIATING DOWN BOTH LEGS, WITH BURNING IN HER LEGS AND NUMBNESS IN HER RIGHT TOES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 44940 | 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 | 00037 YR | Other| R |