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

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

Patient Problems Stenosis (2263); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6) (b)(4).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) 2010, patient underwent following procedure: lumbar laminectomy, foraminotomy, facetectomy at l3-4 and l4-5 levels bilatera lly; for pre-op diagnosis of lumbar foraminal stenosis at l3-4 and l4-5 bilaterally.No complications were reported.On (b)(6) 2010, patient underwent following procedure: lumbar posterolateral decompression and fusion, l3-l4 and l4-l5 bilaterally; f or pre-op diagnosis of: lumbar foraminal and spinal stenosis at l3-l4 and l4-l5.Per-op notes: ".We were able to put 2 appropriately aligned rods, 70 mm, in the screws bilaterally.We were able to put set screws and tighten those.Given the fact that our imaging was significant for satisfaction with placement of our pedicle screws, we went ahead and sheared off the set screws at each level, and once we were able to do that we prepared our rhbmp-2, which had been cooking for some time and we were able to use local bone graft which we had to put in the rhbmp-2 and place it in gutters bilaterally where we had decorticated tps and facet joints.The skin incision was dressed in a standard sterile fashion, and thereafter the patient was placed from prone to a supine position.Once the patient awoke from anesthesia without any complications, the patient was taken to the recovery room for his post-anesthesia care." on (b)(6) 2011, patient underwent following procedure: removal of instrumentation from l3-5, exploration of fusion from l3-5, re-instrumentation of spine from l2-5 with re-bone grafting from l2-5; for pre-op diagnosis of: spinal stenosis at l2, non-union at l3-4 and l4-5.Per-op notes: ".A straight mid-line incision was made over the lumbar spine, carried down to the tips of the transverse processes with the bovie and dissection was carried out and carefully stripping of the scar tissue from the previous surgery over the lateral gutters.Exploration of the fusion was performed both medially and laterally, particularly laterally after the rods had been removed.There was noted to be a fairly decent fusion over the facet joints but the bone was very scant in the lateral gutters, therefore it was felt that there was non-unions at 3-4 and 4-5.Rods were placed over the heads of the screws, set nuts were sheared off, wound was thoroughly irrigated and bone graft consisting of ulnar graft with large rhbmp-2 equally divided and placed in the lateral gutters, deep drain was placed.There were no complications." on (b)(6) 2012, patient underwent following procedure: anterior lumbar discectomy, l5-s1, anterior lumbar interbody fusion, l5-s1, placement of anterior prosthetic device utilizing implant, l5-s1, placement of supplemental anterior segmental spinal compressive instrumentation, l5-s1, utilizing for anchor plates, rhbmp-2/acs, intra-op fluoroscopy, left retroperitoneal approach; for pre-op diagnosis of: multilevel non-union, status post multiple surgeries with fixation and posterior instrumentation, l2 to l5, spondylosis, l5-s1, loose instrumentation, chronic pain syndrome, cervical spondylosis without radiculopathy or myelopathy.Per-op notes: ".When the anterior spine had been exposed intra-operative fluoroscopy was used to ascertain the appropriate level.Utilizing appropriate instruments such as curette, osteotome and rongeurs, a discectomy was accomplished at l5-s1.Bleeding end-plates were noted.The bone graft material was then placed into the anterior prosthetic device which had been cut to appropriate dimensions.Once the cage was seated under fluoroscopy in the ap and lateral planes and found to be in an appropriate position, the appropriate size fixation plates were selected.The first plate was placed into the jig in either an upward or down-going direction and advanced utilizing a series of bone tamps.".

• 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: 5479744
• MDR Text Key: 39655292
• Report Number: 1030489-2016-00605
• 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: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention