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 Pain (1994); Stenosis (2263)

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.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 on (b)(6) 2006 the patient presented with following preoperative diagnosis : degenerative disc disease at l4-5.The patient underwent the following procedures: 1) posterolateral arthrodesis at l4-5.2) posterior non segmental fixation at l4-5.3) interlaminectomy at l4-5.4) allograft and bone morphogenic protein (bmp).Per op notes: cancellous allograft chips and bone morphogenic protein were utilized to facilitate the posterolateral fusion.The bmp was laid and impacted into the decorticated facet joint and posterolateral intertransverse process region.Patient's post-operative period was marked by temporary relief followed by increasingly severe low back pain, with radiating pain into her lower extremities.A ct scan taken on (b)(6) 2009 revealed disc bulges at the level of the rhbmp-2/collagen sponge surgery resulting in moderate impingement of her nerve roots.A ct scan taken on (b)(6) 2014 revealed calcification of the posterior disc space and facet hypertrophy causing moderate to severe neuroforaminal stenosis at the level of the surgery site.Currently, patient continues to experience severe and unrelenting low back pain that radiates into her left hip and both of her lower extremities.

• 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: 5331492
• MDR Text Key: 34528841
• Report Number: 1030489-2015-03593
• 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
• Report Date: 11/30/2015

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/29/2015
• 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