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 Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Inadequate Pain Relief (2388); Numbness (2415); Ambulation Difficulties (2544)

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) 2005, the patient underwent transforaminal lumbar interbody fusion and posterolateral fusion surgery from vertebrae l4 to l5.Reportedly, rhbmp-2/acs was used in this surgery.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space and over the posterolateral elements).Post-op, the patient suffered from increasing low back pain, pain radiating into her left leg.Severe pain and symptoms ultimately compelled patient to undergo a risky, painful and costly revision surgery on (b)(6) 2008.Despite revision surgery, patient continued to experience constant pain and swelling in the lower left side of her back, with radiating pain into her hip and left leg.She experienced difficulty in sitting, standing, and walking, with numbness in her left leg if she sits for an extended period.These serious injuries prevent patient from practicing and enjoying the activities of daily life.

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 presented with following pre-op diagnosis: l4-l5 degenerative disc disease and herniated nucleus pulposus with discogenic low back pain and radiculopathy.The patient underwent the following procedures: bilateral minimally-invasive exposure of the l4-l5 level.Right-sided l4-l5 facetectomy, foraminotomy, and transforaminal lumbar interbody fusion using a peek interbody spacer, locally harvested autograft, and bmp allograft.Bilateral l4-l5 pedicle screw fixation.Bilateral l4-l5 posterolateral arthrodesis using locally harvested autograft and bmp allograft.As per operative notes, "the trial spacer was then removed, and bmp allograft was mixed per protocol.A rolled-up bmp sponge with morselized autograft was then packed into the far anterolateral aspect of the empty disc space.A 12 x 22 mm peek interbody spacer was then packed using bmp and morselized autograft and tamped into the disc space to an appropriate depth as guided by intraoperative fluoroscopy.Autograft was then packed over the right-sided posterolateral elements to enact the arthrodesis there.A combination of bmp allograft and morselized autograft were packed over the left-side posterolateral elements to enact the arthrodesis there.¿ no intra-operative complications were reported.

• 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: 5768562
• MDR Text Key: 48715713
• Report Number: 1030489-2016-01988
• 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: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• 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: M114006AAG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2018
• 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