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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neuropathy (1983); Paralysis (1997); Inadequate Pain Relief (2388); Numbness (2415)

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.

Event Description

It was reported that on (b)(6) 2010, patient underwent a spine fusion surgery from l4 to s1.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space, transverse process and lateral sacral ala).Allegedly, patients post-operative periods have been marked by a period of improvement, followed by return of progressively worsening lower back pain and radicular symptoms in both lower extremities.Severe pain and symptoms ultimately compelled patient to undergo four risky, painful and costly revision surgeries.Despite multiple revision surgeries, the patient continued to experience chronic lower back pain, with pain radiating down to her hips and right leg, numbness in parts of her back and left leg, and paralysis of her right leg.Patient also suffered from bladder and bowel dysfunction.

Manufacturer Narrative

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

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 large recurrent left l4-l5, probably extruded herniated nucleus pulposus with diskography proven painful disk degeneration of l5-s1 and underwent the following procedures: 1) revision, total l4 and l5 gill-type and l5-s1 gill-type laminectomy with left l4-l5 and l5-s1 total facetectomy, right l4-l5 and l5-s1 medial facetectomy, and then revision left l4-ls microdiskectomy and primary left l5-s1 radical diskectomy.2) left approach l4-l5 and l5-s1 tlif (transforaminal lumbar interbody fusion), implanting at l4-l5 a 14 x 26 mm allograft implant augmented by a burrito of bone morphogenic protein (bmp) from a large packet, and morselized local autograft, and at l5-s1 a 10 x 26 mm allograft implant, again with a burrito of bone morphogenic protein (bmp) local autograft.3) l4-s1 posterior instrumented transverse to alar fusion utilizing segmental fixation, large packet of bone morphogenic protein (bmp) morselized local autograft.4) intrathecal instillation of 20 mcg of fentanyl.As per op-notes,¿ we then worked through the epidural scar at the previous left l4-ls laminotomy, utilizing microdissection, developed the epidural plane.We did encounter ultimately a large recurrent disk at l4-l5, which was incised and then on the left at l4-l5 and on the left at l5-s1, performed a radical diskectomy, utilizing the collis disk and endplate chisels for disk removal, multiple passes with pituitary, until to our satisfaction, removed the majority of the disk, all the recurrent disk at left l4-ls, and prepared the endplates for acceptance of tlif allograft bone.We then templated at l4-ls and chose a 14 x 26, at l5-s1 a 10 x 26.We first packed the ventral disk with a burrito of bmp with a pledget of bmp from a large packet around morselized local autograft, debrided of soft tissue, passed through the bone mill, and then initially tamped the allograft in obliquely, and then tamped it to lie transversely in the ventral half of the respective disk space with excellent fit and fill at both levels.¿ the patient tolerated the pro cedure 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6207988
• MDR Text Key: 63359219
• Report Number: 1030489-2016-03554
• 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,Followup
• Report Date: 12/18/2017

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
• Device Expiration Date: 01/01/2012
• Device Catalogue Number: 7510600
• Device Lot Number: M110809AAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: 12/05/2016; 12/27/2017
• Supplement Dates FDA Received: 09/27/2017; 12/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2009
• 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