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 Fall (1848); Neuropathy (1983); Pain (1994); Injury (2348); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

Approach: transforaminal lumbar interbody fusion it was reported that on (b)(6) 2008, patient underwent a spinal fusion surgery on the lumbar region of her spine from l4-5 using rhbmp2/acs.The rhbmp2 collagen sponge was placed outside the cage.Patient underwent surgery using transforaminal approach.Patient post-operative period had been marked by a period of improvement, followed by increasingly severe and chronic low back pain, with pain and radiculopathy into her left buttocks and left leg.As a result, patient experiences loss of balance and has sustained multiple falls, which have caused knee and shoulder injuries requiring surgeries.Patient uses a cane or walker when ambulating and is unable to perform many errands and household chores.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was pre-operatively diagnosed with recurrent disc herniation, left l4-l5 and underwent the following procedures: 1) revision of lumbar laminectomy, l4-l5 with foraminotomy.2) posterior lumbar interbody fusion through a tlif approach.3) insertion of intervertebral cage, 9mm height, peek system at l4-l5, for purpose of fusion.4) posterior spinal instrumentation using expedium pedicle screws and polyaxial titanium.5) local bone graft augmented with bmp and allograft material and with allograft bone chips for purpose of fusion.As per op-notes,¿ after all the pedicle screws were placed, distraction was applied to the left ¿sided pedicle screws and the exiting traversing nerve roots were protected.Shavers were introduced from size 6 to size 10 and then trials up to size 9 were fit best into the disk space.The disk contents were evacuated with pituitary rongeurs and end plates were decorticated using curettes of various sizes and shapes.Next, the disk space was packed with bmp and with localized morselized bone graft as well as allograft.When this was done, a 9 mm banana shaped peek cage was impacted.The distraction was removed and the screws were compressed over a 5.5 mm titanium rod.¿ the patient tolerated the procedure well without any intraoperative complications.

• 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: 5403441
• MDR Text Key: 37302937
• Report Number: 1030489-2016-00362
• 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,Followup
• Report Date: 02/16/2018

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 02/01/2016
• Supplement Dates Manufacturer Received: 01/22/2018
• Supplement Dates FDA Received: 02/16/2018
• 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): Other