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

Catalog Number 7510200

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

Patient Problems Neuropathy (1983); Loss of Range of Motion (2032); Numbness (2415); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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.

Event Description

It was reported that on (b)(6) 2005, the patient underwent cervical discectomy and fusion at levels c6-c7 wherein rhbmp-2/acs was implanted.Post-op, the patient had increasingly severe neck pain, with pain and radiculopathy in her upper extremities.The patient continued to experience chronic neck pain, pain radiating to her back and down her arms, numbness in both hands, and difficulty breathing and swallowing.Plaintiff has limited range of motion in her neck, and experiences pain and difficulty lifting her arms and sitting and standing for extended periods.

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 (b)(6) 2005: the patient was per-operatively diagnosed with herniated nucleus pulposis with radiculopathy at c6-7 and underwent the following procedures: 1) anterior cervical discectomy at c6-7.2) anterior cervical fusion at c6-7.3) anterior cervical plating, c6-7 with a cross, round-hole plate.4) structural allo patella and small bmp grafting.5) repair of small nick to the left vertebral artery under microscope visualization.As per op-notes,¿ prior to repair there was excellent flow from the cranial as well as caudal directions.We then inspected it for about 30 seconds and noted that there were no arterial spasms.Flow appeared to be excellent.There was good pulsation, and therefore we resumed our operation.We had already taken out the disc mostly at this point.We continued with the discectomy and then decorticated the end plates.We found the retroligamentous disc hernia on the right side, took this out, and we then took or allo patella graft and made a small hole in it, sharpening it to an appropriate size of fit into the disc space.We tamped it in place and took a small anterior cervical plate 20mm in length, with two screws into c6, 2 into c7 to obtain an x-ray, which confirmed that these were in good position.¿ 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5549692
• MDR Text Key: 41940431
• Report Number: 1030489-2016-00963
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2007
• Device Catalogue Number: 7510200
• Device Lot Number: M114006AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2006
• 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