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

Catalog Number 7510400

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

Patient Problems Dyspnea (1816); Headache (1880); Neuropathy (1983); Pain (1994); Tingling (2171); Numbness (2415); 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.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) 2008, the patient underwent a spinal fusion surgery on the cervical region of her spine from vertebrae c5 to c7.Reportedly, during the surgery, rhbmp-2/acs was used in the patient.As reported, the patient's post-operative period had been marked by a period of improvement, followed by increasing neck and shoulder pain.Patient continues to experience extreme neck pain, radiating to her shoulders and down her arms, numbness and tingling in her neck and arms, shortness of breath, and constant headaches.These serious injuries prevent patient from practicing and enjoying the activities of daily life that patient enjoyed pre-operatively.

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 presented with the following pre-op diagnosis: left c5-6, right c6-7 cervical disk herniations with bilateral upper extremity radiculopathy.She underwent the following procedure anterior cervical microdiskectomy c5-6, c6-7; anterior interbody arthrodesis c5-6, c6-7 with machined allograft spacers, bone morphogenic protein and anterior cervical plate.As per op-notes,¿ spacer was introduced and 8 mm machined allograft spacer was then selected.Core was drilled out.A small piece of infused bone morphogenic protein sponge was placed within the core and it was gently impacted into place under direct visualization.In a like manner a c5 pin was placed at c7 and in-line distraction was obtained.The disk was incised and removed with pituitary rongeurs.The dissector was used to clear out this space back to the posterior longitudinal ligament.The ligament was taken down.The disk was herniated on the right side.Bilateral foraminotomies were performed.Trial spacer was introduced and a 7 mm graft was selected.¿ no intra-op complications were reported.

• 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: 5549760
• MDR Text Key: 41944226
• Report Number: 1030489-2016-00966
• 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: 03/01/2018

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: 07/01/2010
• Device Catalogue Number: 7510400
• Device Lot Number: M110705AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2008
• 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