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 Fall (1848); Neuropathy (1983); Injury (2348); Ambulation Difficulties (2544)

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) 2011, patient underwent a spinal fusion surgery on the lumbar region of his spine from l4-l5 using rhbmp-2/acs.Patient continued to experience constant and extreme lower back pain, with pain radiating to his legs, numbness extending from his buttock down his left leg, swelling in his lower back, and nerve pain.Patient experienced pain and difficulty sitting, standing and walking for extended periods and requires a cane for assistance in ambulating.His legs constantly give out and he has fallen, resulting in additional injuries.These serious injuries prevent patient from practicing and enjoying the activities of daily life that he enjoyed pre-operatively.

Event Description

It was reported that on: (b)(6) 2011: the patient was preoperatively diagnosed with l4-l5 discogenic back pains and underwent the following procedures: an terior retroperitoneal exposure of l4-5 and subsequent closure.Complete diskectomy of l4-5.Anterior lumbar interbody fusion of l4-5 with cage and bone morphogenic protein.Anterior fixation with plate and screws of l4-5.As per the operative notes, ¿ a series of sizing devices were used, and a 10-degree, 14 mm cougar cage was chosen and implanted with bone morphogenic protein.¿.

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: 5549658
• MDR Text Key: 41939028
• Report Number: 1030489-2016-00956
• 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: 08/07/2017

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: 08/01/2014
• Device Catalogue Number: 7510400
• Device Lot Number: M111101AAB
• 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: 08/07/2017; 08/07/2017
• Supplement Dates FDA Received: 08/18/2017; 09/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2011
• 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