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); Tingling (2171); Numbness (2415); Sleep Dysfunction (2517); 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

Procedure: transforaminal lumbar interbody fusion and posterior fusion surgery.Levels implanted: l5-s1 it was reported that on (b)(6) 2008, the patient underwent spine fusion surgery from vertebrae l5-s1 wherein rhbmp-2/acs was implanted with transforaminal approach.The rhbmp-2 collagen sponge was placed outside a cage (i.E.In the disc space, facet joint and over the lamina).Post-op, the patient complained of increasing low back pain, and associated radiculopathy in her lower extremities.The patient continued to experience chronic lower back pain, with pain radiating to her tailbone and right side.The patient experienced numbness and tingling in right leg and feet, had difficulty in walking and sleeping.

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 the following pre operative diagnosis: l5-s1 lumbar disk herniation and lumbar degenerative disease and lumbar radiculopathy.She underwent the following procedures: l5-s1 transforaminal lumbar interbody fusion with prosthetic interbody vertebral device, infused bone grafting and posterior instrumentation.As per the operative notes,¿ the disk space was irrigated, trial interbody spacers were placed and then removed and a medium bmp has been prepared and sponge of bmp was placed in the left-hand side of the disk space.Matrix was placed behind this.Two sustain interbody implants, 9 mm in height * 12 mm in width * 30 mm in length, each filled with two-thirds of a sponge of bmp the first interbody implant was placed and then tamped over to the left-hand side and a third sponge of bmp was placed in the anterior aspect of the disk space.¿ 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5562464
• MDR Text Key: 42145369
• Report Number: 1030489-2016-01030
• 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: 06/06/2018

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: 07/01/2010
• Device Catalogue Number: 7510400
• Device Lot Number: M110705AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/08/2016
• Supplement Dates Manufacturer Received: 03/10/2016; 05/07/2018
• Supplement Dates FDA Received: 09/21/2017; 06/06/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2008
• 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