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); Dyspnea (1816); Neuropathy (1983); Pain (1994); Tingling (2171); Numbness (2415); Ambulation Difficulties (2544)

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) 2009, patient was admitted to the facility where the surgeon performed spine fusion surgery on the cervical region of his spine from vertebrae c5 to c7.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was applied to cervical spine.Reportedly, "patient's post-operative periods were marked by a period of improvement, followed by increasingly severe mid and lower back pain, radiculopathy, and difficulty breathing, speaking and swallowing.Severe pain compelled patient to undergo implantation of a spinal cord stimulator."allegedly, " patient continues to experience difficulty in breathing, speaking and swallowing, constant mid and lower back pain, with pain radiating down his left side, and numbness and tingling in his left leg.He had difficulty sitting, standing and walking.".

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2009, the patient was pre-operatively diagnosed with pseudoarthrosis, c5-7, radiculopathy, c5-6, herniated disc, c5-6 and previous anterior cervical plate fixation, c6-7 and underwent the following procedures: 1) removal of implants of anterior spine, c6-7.2) exploration of spinal fusion, c6-7.3) revision arthrodesis, c6-7.4) application of peek interbody graft with bone morphogenic protein, c6-7.5) anterior cervical discectomy, c5-6.6) anterior cervical arthrodesis, c5-6.7) anterior cervical plate fixation, c5-c7.8) application of peek and bone morphogenic protein at c5-6.Indications for procedure: the patient had a previous right-sided approach for his anterior cervical discectomy and fusion (acdf), which resulted in temporary vocal cord paralysis and dysphagia.The patient also underwent an esophageal myotomy on the left-sided approach.As per op-notes, ¿i used a bur continually until i could proceed deep enough to place a 9 x 14 x 14 peek interbody graft.I checked with fluoroscopy to ensure this was in appropriate position, as well as with direct visualization.Again, i debrided the endplates with a curette to ensure i had good bleeding bone and made some punctate depressions in the bone with the small curette.I ensured i had good bleeding surfaces on both the superior and inferior endplates, and therefore impacted the peek 9 x14 x 14-mm graft that was filled with one third of an rhbmp-2 sponge.This impacted well into place.¿.

• 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: 6019972
• MDR Text Key: 57052326
• Report Number: 1030489-2016-02852
• 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: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• 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: 08/14/2017
• 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