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 Fall (1848); Pain (1994); No Code Available (3191)

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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that: on an unknown date, in 2010 the patient experienced pain in her lower back that radiated down both of her legs , as well as muscle spasms that brought about instability while standing.On an unknown date, the patient went for an office visit, where the surgeon reviewed patient's mri films and recommended surgery.On (b)(6) 2010, the patient underwent surgery consisting of a spinal fusion from l3-l4 and l4-l5 using rhbmp-2/acs.Patient also underwent physical therapy and pain medication post the surgery.Shortly after the surgery, patient's pain began to increase.Patient suffered from severe pain in both legs and was often falling down without warning when her legs would no longer support her.Patient continued to suffer from increased pain for almost a year post the surgery.

• 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: 6492834
• MDR Text Key: 72779025
• Report Number: 1030489-2017-00863
• 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
• Report Date: 03/21/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/14/2017
• Supplement Dates Manufacturer Received: 03/21/2017
• Supplement Dates FDA Received: 10/02/2017
• 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