MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Anemia (1706); Diarrhea (1811); Nausea (1970); Neuropathy (1983); Pain (1994); Swelling (2091); Vomiting (2144); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

It was reported that on, (b)(6) 2014, patient was admitted for scoliosis and kyphoscoliosis.Patient underwent l5-s1 ap fusion.On (b)(6) 2014, patient underwent following procedure: anterior exposure of lumbar spine, l5-s1; neural monitoring; fluoroscopy; for pre-op diagnosis of: spondylolisthesis, l5-s1; failed previous surgery with implant failure and non-union; persistent pain and recurrent deformity.No complications were reported.On (b)(6) 2014, patient underwent following procedure: anterior surgical approach, l5-s1; complete revision discectomy, l5-s1, anterior; removal of bony overgrowth and partial corpectomy at l5 for anterior spinal fusion, l5-s1; complete decompression at l5-s1 bilaterally; placement of a synthetically machined structural allograft bone cage, l5-s1; use of bmp for anterior spinal fusion, l5-s1; use of allograft bone powder for anterior spinal fusion, l5-s1; posterior revision surgical approach, l5-s1; removal of broken screw tips, s1, bilaterally; placement of pedicle screws, l5 and s1, bilaterally; use of stealth intraoperative computer assisted surgical navigation for placement of pedicle screws, l5 and s1, bilaterally; neural monitoring; fluoroscopy; revision partial laminectomy at l5, bilaterally; posterior spinal fusion, l5-s1; use of allograft bone powder and residual bmp for posterior spinal fusion, l5-s1, posterior; for pre-op diagnosis of: previous attempted lumbar spinal fusion, l5-s1, with wound infection and broken hardware and residual hardware removal with tips of broken screws imbedded in the bone and rem aining in place, and now with nonunion and residual stenosis and instability.Per-op notes: once exposure was obtained, anterior disc was removed.Partial corpectomy was done at l5 to remove the scar tissue and previous fusion material.After this decompression of spinal canal and nerve root was carried out.After this synthetically machined structural allograft filled with bmp and artificial bone powder was placed in the interbody space.Under fluoroscopy cage appeared in good position.Additional bmp and bone powder was placed next to the cage.For posterior approach incision was made from l4 to s1.Pedicle screws were placed bilaterally at l5 and s1.Once screws were in place they were locked together with titanium rods.Residual bmp and allograft bone powder were placed, especially over the left side, the screws and rods were locked using set screws and torque locking mechanism.No complications were reported.On (b)(6) 2014, patient underwent o-arm x-ray.Impression: intra-op o-arm acquisition demonstrating appropriate position of l5-s1 femoral allograft ring, l5 and s1 paired pedicle screws.On (b)(6) 2014, patient underwent x-ray of lumbar spine.Impression: no evidence of hardware failure.On (b)(6) 2014, patient was discharged with following diagnosis: spinal ; degeneration of lumbar intervertebral disc; acquired spondylolisthesis; acquired muscoskeletal deformity; chronic pain; disorders of sacrum; thoracic or lumbosacral neuritis or radiculitis, unspecified; dysthymic disorder.On (b)(6) 2014, patient presented in emergency department due to increasing back pain.Patient underwent ct of abdomen/pelvis without contrast.Impression: a 9.8cm fluid and gas collection in the anterior abdominal wall is suspicious for abscess.There is a second 3cm fluid collection within the musculature in the left ventral abdominal wall that may be sterile or infected; post surgical changes of l5-s1 corpectomy and posterior fusion.Ill-defined presacral soft tissue/edema with scattered foci of gas could be post surgical, although infection cannot be entirely excluded.No organized fluid collection to suggest abscess; scattered foci of gas in the left retroperitoneum are presumably post surgical.Small amount of pelvic free fluid; non-obstructing right renal stones.Patient underwent ultrasound of bilateral lower extremity.Impression: no evidence of deep vein thrombosis in the lower extremities.Prominent bilateral inguinal lymph nodes.On (b)(6) 2014, patient underwent procedure for incision debridement and washout of wound infection, anterior lumbar incision.No complications were reported.The patient also underwent ct scan of the abdomen.Impressions: ventral abdominal wall abscess, incrementally decreased in soze since the prior exam.Second, smaller adjacent compression has also decreased in size.Asymmetric foci of ags within the left retroperitoneum.Likely resolving postsurgical gas; stable non obstructing right nephrolithiasis and subentimeter hypodensity, likely a simple cyst; stable non specific hypodense lesion in the posterior right hepatic lobe; stable mild intrahepatic bile duct dialation.The patient was also presented for office visit with following problem list: anxiety, renal calculi, lumbago, status post lumbar spinal fusion, sacroiliac joint pain, piriformis syndrome of right side, lumbar radiculopathy, post op infection, chronic calculous choleccytitis, kidney stone, iron deficiency anemia.On (b)(6) 2014: patient underwent chest x-ray ap portable.Impression: right tip projects in the lower svc.On (b)(6) 2014: patient admitted in hospital due to diarrhea, nausea and vomiting.On (b)(6) 2014 patient presented due to wound infection, abscess of abdominal wall, myrositis, leukocytosis, thrombocytosis, picc (peri pherally inserted central catheter) in place.Patient underwent chest x-ray.Patient underwent x-ray of lumbar spine.Per records, radiology studies independently visualized and are pertinent for ap and lateral of the lumbar spine demonstrated stable alignment of the anterior interbody space, as well as the hardware which was in place at l5-s1.There is no evidence of fusion across the interbody graft.The patient presented with diagnosis of s/p lumbar spine and underwent x ray spine : lumbar spine 2 views.On (b)(6) 2014, the patient was admitted in the facility.Final diagnosis included ; lumbago; nausea with vomiting ; anemia ; calculus of gallbladder w/o mention of cholecystitis.The patient underwent us abdomen.Impression : large gallbladder.Cholelithiasis.No bile duct dilatation.Impression.Imaging study of ct abdomen / pelvis shows intact l5-s1 psf and asf hardware but also shows b/i nonobstructing intrarenal collecting systems as wells and small hyperdense foci in the gallbladder and finally almost resolved anterior wall fluid.The patient was discharged next day.On (b)(6) 2014, the patient was admitted to the facility.Reason for visit was back pain.The patient underwent x-ray of lumbar spine.Impression : l5-s1 decompression and fusion with early bony incorporation across interbody graft.The patient was also referred to physical therapy.On (b)(6) 2015, the patient presented with chronic low back pain.On (b)(6) 2015, the patient presented for follow up.The patient diagnosis were low back pain; s/p lumbar fusion and bilateral low back pain w/o sciatica.On (b)(6) 2015, the patient visited the facility requesting medicine refill.On (b)(6) 2015, the patient presented for f/u on back after child birth on (b)(6) 2015.Patient diagnosis was sacroiliac dysfunction.The patient underwent x ray of lumbar spine.Impression : l5-s1 bilateral posterolateral fusion without acute abnormality.On (b)(6) 2015, the patient requested for medicine refill.On (b)(6) 2015, the patient visited for medicine refill.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5403603
• MDR Text Key: 37303569
• Report Number: 1030489-2016-00368
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 7510200
• Device Lot Number: M111114AAO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 54