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

Catalog Number 7510400

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

Patient Problems Stenosis (2263); Collapse (2416)

Event Type  Injury  

Manufacturer Narrative

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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on, (b)(6) 2002 the patient underwent anterior lumbar interbody fusion of l5-s1 with cages and allograft bone.Preoperative diagnosis: lumbar spondylosis of l5-s1.Per-op notes: ¿once the level had been identified, a complete l5-s1 discectomy was performed.There was noted to be near complete collapse of the l5-s1 disc space and the cages were then placed according to manufacturer¿s specimens, using the initial dilators, up to 10mm, followed by placing of distractors and the tang.A 14x20mm cage was felt to be appropriate size.The interspace was then reamed and the cages were placed, after having been filled with bone morphogenic protein sponges.Also prior to placing the cages with distraction, looking into the posterior space, there was no obvious indentifiable disc fragments that ere left.¿ on (b)(6) 2007 the patient underwent x rays of the shoulder.Impressions: there is moderate degenerative disc disease at c5-6 and c6-7.On (b)(6) 2008 the patient underwent cervical spine.Impression: multilevel disc dessication and endplate degenerative changes throughout the cervical spine; c3-4: severe left foraminal narrowing with a combination of left lateral posterior disc osteophyte complex, spurring and moderate to severe left facet degenerative changes.On (b)(6) 2008 the patient underwent x rays of the lumbar spine.Impression: flexion and extension views of the lumbar spine demonstrate interval development of degenerative disc changes at l3-4 with instability on flexion.Postoperative findings in the lower lumbar spine re demonstrated.On (b)(6) 2008 the patient was presented for office visit.Diagnosis: spondylolisthesis and lumbar spinal stenosis.

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.

• 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: 5688020
• MDR Text Key: 46158580
• Report Number: 1030489-2016-01591
• 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: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510400
• Device Lot Number: MB111008A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/28/2018
• 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): Required Intervention
• Patient Weight: 108