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 Dizziness (2194); Injury (2348); 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 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

Per medical records it was reported that patient underwent a spinal fusion on (b)(6) 2010, which had select parts of rhbmp-2(i.E.The rhbmp-2 and collagen sponge) was used in an anterior cervical discectomy and fusion surgery.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was applied to the cervical spine.Patient complained of increasingly severe and chronic neck pain, right shoulder and arm pain, headaches, dizziness, and a metallic taste in her mouth.Patient has increased blood pressure due to pain.Patient alleged to have suffered serious and permanent injuries.

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 c4-c5 and c5-c6 cervical disc herniation with left upper extremity radiculopathy and underwent the following procedures: anterior cervical microscopic discectomy at c5-c6 and c6-c7, bilateral foraminotomies at c5-c6 and c6-c7, anterior interbody arthrodesis at c5-c6 and c6-c7 with synthes machined allograft spacers, bone morphogenic protein, and slim-loc anterior cervical plate.As per op-notes,¿ the posterior longitudinal ligament was torn and an extruded fragment of disc had become sequestered behind the ligament in the spinal canal and left c6-c7 neuroforamen.The area was completely taken down.The disc was removed.Bilateral foraminotomies were performed.The endplates were prepared and the space was again measured at 8mm.An 8-mm corticocancellous machined allograft spacer was selected.A small hole was drilled in the cancellous portion.A small piece of bmp was placed within tit and it was gently impacted into place under direct visualization.¿ 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5388006
• MDR Text Key: 36757109
• Report Number: 1030489-2016-00274
• 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
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• 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: 12/18/2017
• 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