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); Burning Sensation (2146); 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.Although it is unknown if the device 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 (b)(6) 2012, patient underwent an anterior cervical discectomy and fusion surgery from vertebrae c2 to c5.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.Allegedly, "patient's post-operative period was marked by a period of improvement, followed by increasingly severe neck and shoulder pain, headaches, radiculopathy into her upper extremities, and paresthesias in her hands.Patient continues to experience chronic neck pain, with pain radiating to her shoulders and arms, tingling in her fingers, constant headaches, and burning sensations radiating from her head.Patient also experiences intermittent difficulty breathing and swallowing¿.Due to severe pain and symptoms, the possibility of a revision surgery has been discussed.

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 on: (b)(6) 2012: the patient was pre-operatively diagnosed with cervical congenital stenosis, c3-4 cervical disc herniation with moderate stenosis, c4-5 disc herniation and spondylosis with moderate stenosis and underwent anterior cervical microscopic discectomy and arthrodesis, c3-4,c4-5, with machined allograft spacers, bone morphogenic protein (bmp), and a skyline anterior cervical plate.As per operative notes,¿ the spinal cord was decompressed and bilateral foraminotomies were performed.Following hemostasis, the endplates were prepared.The space was measured as 7 mm and a 7 mm machined allograft spacer was selected.A small hole was drilled in the spacer and a very small fraction of bone morphogenic protein sponge was placed within the confines of the spacer.The spacer was impacted into place under direct visualization.¿ the patient tolerated the procedure well without any intraoperative complications.The patient was discharged from the facility on (b)(6) 2012.

• 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: 6208020
• MDR Text Key: 63358661
• Report Number: 1030489-2016-03585
• 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: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 7510050
• Device Lot Number: M111116AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2012
• 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