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

Catalog Number 7510600

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

Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Neuropathy (1983); Pain (1994); Swelling (2091); Dysphasia (2195); Neck Pain (2433); Neck Stiffness (2434); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

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.Above mentioned device with quantity of 2 was involved in the event.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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent spine fusion surgery on cervical and thoracic region of spine from vertebrae c2 to t2.The rhbmp-2 and collagen sponge were used in the surgery.Post-op, patient experienced progressively worsening and chronic neck and back pain, stiffness and soreness; difficulty speaking, swallowing and breathing; swelling in his neck and hands; and radiculopathy in both legs, feet and in his left arm.Patient required use of crutches or a cane to assist with ambulation.These serious injuries prevent the patient from practicing and enjoying the activities of daily life that patient enjoyed pre-operatively, and had otherwise suffered serious and permanent injuries.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7147212
• MDR Text Key: 95790158
• Report Number: 1030489-2017-02570
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843812
• UDI-Public: 00681490843812
• 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
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2014
• Device Catalogue Number: 7510600
• Device Lot Number: M111103AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2011
• 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