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

Catalog Number 7510100

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

Patient Problem No Code Available (3191)

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 the patient underwent following procedures: left l4-5 transforaminal lumbar interbody fusion using peek spacer, and autograft.Posterior instrumentation with pedicle screws and posterolateral fusion with autograft, allograft, and bmp-2.Preoperative diagnosis: l4-5 degenerative disc.Left l4-5 stenosis.As per op notes: ¿next, a 12mm graft was packed with morcellized fit snugly.Morcellized autograft was then packed medial and lateral to the spacer.Next, attention was turned toward the facet joint on the right.This was decorticated and packed with morcellized autograft as well as bmp-2 autograft, a little bit of allograft, and bmp-2 sponge.On the left hand side, the lateral recess was decorticated and packed with morcellized allograft.¿.Post operatively the patient reported disc herniation and underwent a revision surgery in (b)(6) 2011.

Manufacturer Narrative

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.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6649472
• MDR Text Key: 77822252
• Report Number: 1030489-2017-01596
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00613994239525
• UDI-Public: 00613994239525
• 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: 05/22/2017

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: 07/01/2011
• Device Catalogue Number: 7510100
• Device Lot Number: M111051AAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/19/2017
• Supplement Dates Manufacturer Received: 05/22/2017
• Supplement Dates FDA Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2010
• 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