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); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Neck Pain (2433); Choking (2464)

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 an anterior cervical discectomy and fusion surgery on the cervical region of his spine from vertebrae c5 to c7.Reportedly, patient was implanted with rhbmp-2/acs in this surgery.Allegedly, the patient's post-operative period was marked by ¿a period of improvement, increasing neck pain and radiculopathy in his upper extremities.¿ patient continues to experience ¿chronic neck pain and limited range of motion, pain radiating down to his shoulders and arms, radicular symptoms in his arms, and swelling in hands.Patient also experiences difficulty swallowing, and was constantly choking on food.¿.

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.

Event Description

It was reported that on the patient was pre-operatively diagnosed with 1) cervical hnp.2) cervical spinal stenosis.3) cervical disc degeneration.4) intractable neck pain.5) cervical radiculopathy and underwent the following procedures: 1) anterior cervical discectomies with spondylectomies at c5-6 and c6-7.2) anterior cervical fusion at c5-6 and c6-7.3) insertion of interbody implant consisting of 10 mm interbody implant at c5-6 and 9 mm interbody implant at c6-7.4) anterior cervical plating from c5 to c7.Pre-operatively diagnostic studied revealed evidence of disc protrusion at c6-7 and degeneration at c5-6 and c6-7 with foraminal narrowing and stenosis.As per op-notes,¿ decompression at both levels was completed until nerve roots were free of compression.Then at each level, vertebral spreaders were inserted to maximize distraction.A sizing tool was used to determine an appropriate size implant at each level.The implants were then selected and 80% of the central cord of the implant was resected and then a small piece of gelfoam saturated with bmp was applied within the implant itself.The implants were then inserted into the disc space and tamped into position with a bone tap and mallet until it was properly positioned.The tissue surrounding the implant was then filled with fibrin glue minimizing the risk of loosing of the bmp from the surround tissues.The wound was irrigated and dried and a plate of appropriate length was applied from c5 to c7.¿ the patient tolerated the procedure well without any intraoperative complications.

• 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: 6019926
• MDR Text Key: 57053197
• Report Number: 1030489-2016-02843
• 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: 12/22/2017

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: 08/01/2012
• Device Catalogue Number: 7510050
• Device Lot Number: M111102AAF
• 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; 12/04/2017
• Supplement Dates FDA Received: 09/25/2017; 12/22/2017
• 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