MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neuropathy (1983); Pain (1994); Tingling (2171); Depression (2361); Numbness (2415); Post Operative Wound Infection (2446); 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.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 any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 (b)(6) 2006, the patient underwent a spinal fusion surgery on the thoracolumbar region of his spine from vertebrae t5 to l3.Reportedly, during the surgery, rhbmp-2/acs was used in the patient.It was also reported that the rhbmp-2 collagen sponge was placed outside a cage (i.E., in the posterolateral gutters).As reported, the patient's post-operative period had been marked by a superficial and deep wound infection requiring multiple irrigation and debridement procedures.Patient eventually experienced a period of improvement, but his back pain subsequently returned and became increasingly severe.Patient continues to experience chronic back pain, pain radiating to his legs, numbness and tingling in his feet, and headaches.Patient experiences difficulty sitting, standing and walking, and suffers from severe depression as a result of his pain and limitations.These serious injuries prevent patient from practicing and enjoying the activities of daily life that patient enjoyed pre-operatively.

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: 5562203
• MDR Text Key: 42144774
• Report Number: 1030489-2016-01022
• 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: 01/03/2018

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 Catalogue Number: 7510800
• 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; 12/18/2017
• Supplement Dates FDA Received: 09/20/2017; 01/03/2018
• 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): Other