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

Catalog Number 7510050

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

Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Headache (1880); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Tingling (2171); Neck Pain (2433)

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.

Event Description

It was reported that on (b)(6) 2011, the patient underwent anterior cervical discectomy and fusion surgery on the cervical region of his spine from vertebrae c5 to c7.Allegedly, patient was implanted with rhbmp-2/acs in this surgery.Reportedly, "patient's post-operative period was marked by a period of improvement, followed by increasing neck pain and radiculopathy in his upper extremities." reportedly, "patient continues to experience constant neck pain, with pain radiating to his shoulders and upper to mid back, headaches, limited range of motion in his neck, and tingling in his fingers.He is unable to hold head up for extended periods, turn his head, or raise his shoulders.He experiences difficulty swallowing and breathing.Patient is no longer able to drive.".

Manufacturer Narrative

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented with following pre-op diagnosis: upper extremity radiculopathy with neck pain and c5-6 and c6-7 herniated disks.He underwent following procedures: c5-6 and c6-7 anterior cervical discectomies; c5-6 and c6-7 fusion; use of peek spacers at c5-6 and c6-7; use of plate with instrumentation from c5 to c6 to c7; use of allograft; use of bone morphogenic protein; use of operating microscope.As per operative notes,"good decompression was obtained of both nerve roots and confirmed with a blunt nerve hook.The end-plates were then rasped and sized up for a #7 peek interbody spacer packed with bone morphogenic protein and allograft.The end-plates were rasped and sized up for a #7 peek interbody spacer packed with bone morphogenic protein and allograft¿.No intra-operative complications were reported.

• 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: 6019916
• MDR Text Key: 57052731
• Report Number: 1030489-2016-02839
• 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: 05/11/2018

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: 08/01/2012
• Device Catalogue Number: 7510050
• Device Lot Number: M111102AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: 09/19/2016; 04/30/2018
• Supplement Dates FDA Received: 09/25/2017; 05/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/06/2011
• 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