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

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

Patient Problems Dysphagia/ Odynophagia (1815); Neuropathy (1983); Loss of Range of Motion (2032); Tingling (2171); Dysphasia (2195); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517)

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.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 18 (b)(4) 2008, the patient underwent spine fusion surgery on the cervical region of her spine at levels c5-c7 wherein rhbmp-2/acs was implanted.Post-op, the patient had progressively worsening chronic and extreme neck pain with limited range of motion in her neck.She had pain radiating to her upper back and across her shoulders, down her right arm, and sometimes her left arm, and numbness and tingling in her fingers.The patient experienced pain in her throat, and difficulty swallowing and speaking.She also experienced depression, anxiety and difficulty sleeping.

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.

Manufacturer Narrative

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

Event Description

It was reported that the patient was pre-operatively diagnosed with c5-6 and c6-7 cervical nonunion with recurrent stenosis and radiculopathy and underwent the following procedures: c5-6 and c6-7 revision anterior cervical discectomy and fusion with machined allograft interbody spacer, anterior instrumentation; rhbmp2 bone grafting and c5-6 and c6-7 decompression.Pre-operatively, ct scan demonstrated settling of the grafts into the bony endplates with recurrent stenosis and nonunion at both levels.As per op-notes,¿ a high speed burr was used to take down the posterior margins of c5 and c6 and bone spurs in the right neural foramen.The disc space was then irrigated.A 9-mm lordotic machined allograft cortical spacer was filled with ½ sponge of rhbmp-2/acs and impacted on the disc space, achieving a good fit.Local bone from the approach was impacted around the interbody graft.Attention was then turned to the c6-7 level.Casper pins were placed and distractors were applied.Once again, the old graft was removed and endplates were flattened.Decompression was performed by distracting the vertebral bodies as had been done at the level before as well as a high speed burr taken down posterior osteophytes.Once again, wound decompression was completed, a 9-mm lordotic graft with a ¼ sponge of rhbmp-2/acs was impacted on the disc space achieving a good fit.¿ 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: 5546829
• MDR Text Key: 41828164
• Report Number: 1030489-2016-00936
• 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,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2017
• 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