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

Catalog Number 7510600

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

It was reported that the patient sustained unspecified injuries following the use of rhbmp-2/acs in an unspecified spinal fusion surgery.No additional information was reported.

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 the patient had undergone numerous previous operations, including a fusion from l1 to the sacrum.She developed a pseudoarthrosis and the doctor had revised her approximately two years previously, by putting interbody fusion cages at l5-s1, redoing the sacral pedicle screws and using bone morphogenic protein.Despite this, she had gone on to a second pseudoarthrosis at this level.For several months postoperatively, her pain was improved and then as the fixation at l5-s1 loosened.Her symptoms returned.These were predominantly back pain, but she also pain and numbness into the bottom of her foot in an s1 distribution.The patient presented for surgery with pre-operative diagnosis of lumbar degenerative disk disease status post l1 to sacrum fusion, previous t11-l1 decompression and instrumentation and fusion, and pseudoarthrosis at l5-s1.The patient underwent: explantation of internal fixation from t11 down to the sacrum; exploration of fusion mass; bilateral iliac crest bone graft harvest; l5-s1 posterolateral fusion with interbody device, bone morphogenetic protein, local bone, plus allograft; and internal fixation from l2 to ileum.Per op notes, the previous hardware was exposed.This was a plate rod combination with sub-laminar wires up to t11 with pedicle screws from l2 down to s1.All of the hardware was removed with the exception of the pedicle screws from l2 to l5.The fusion was completely solid from l1 down to l5.There was clear motion at l5-s1.The pseudoarthrosis site was identified.Cancellous of bone, both above and below, was burred and exposed.A decompression was carried out at l5-s1 bilaterally and a third interbody fusion cage was placed on the patient's right side at l5-s1.This cage was packed with bone morphogenic protein.Bone graft was then packed into position from l5 down to ala and this included local bone, cancellous allograft, and bone morphogenic protein.Once this was in place, pedicle screw instrumentation was placed from l2 down through l5, leaving out the screws in s1 and then bilateral iliac bolts.This resulted in excellent purchase.The region of the previous pseudoarthrosis at l5-s1 was decorticated.The posterolateral gutters were packed with local bone, bone morphogenic protein, croutons, or cancellous allograft.Once the instrumentation was completed from l2 to the ileum, minus the sacrum, and the instrumentation was secured, the nerve roots were secured and found free of compression.The construct seemed to be very solid from l2 to the sacrum.X-rays showed the instrumentation to be in good position.In intraoperative x-ray showed excellent position of the screws, excellent sagittal alignment of the iliac bolts.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3600341
• MDR Text Key: 4091765
• Report Number: 1030489-2014-00319
• 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,Health Professional
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 01/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510600
• Device Lot Number: M114005AAN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/06/2005
• 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