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); Loss of Range of Motion (2032); Weakness (2145); Burning Sensation (2146); Tingling (2171); Inadequate Pain Relief (2388); Ambulation Difficulties (2544); Nerve Proximity Nos (Not Otherwise Specified) (2647)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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) 2008, the patient underwent spine fusion surgery from vertebrae l4-s1 wherein rhbmp-2/acs was implanted with posterior approach.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was placed outside a cage (i.E.In the posterolateral elements).Post-op, the patient complained of increasingly severe low back and right leg pain, burning pain in her buttocks, and bilateral groin pain.Patient symptoms necessitated spinal injections and eventual implantation of a spinal cord stimulator.Severe pain and symptoms led the patient to undergo revision surgery on (b)(6) 2013.The patient continued to experience chronic and severe lower back pain, with pain radiating down both legs, sciatic nerve pain, numbness and tingling in her lower back and down her legs, and weakness in her legs.Patient must constantly move positions, spends much of her time in bed, and suffered from depression as a result of pain and limitations.The patient experienced difficulty in sitting, standing and walking, and required use of a cane and a walker for assistance.These 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.

• 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: 5549424
• MDR Text Key: 41938184
• Report Number: 1030489-2016-00948
• 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: 10/01/2010
• Device Catalogue Number: 7510400
• Device Lot Number: M110706AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/06/2016
• Supplement Dates Manufacturer Received: 03/10/2016; 05/07/2018
• Supplement Dates FDA Received: 09/20/2017; 06/06/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2008
• 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