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 Neuropathy (1983); Pain (1994); Weakness (2145); 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.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on (b)(6) 2012, patient underwent an anterior cervical discectomy and fusion surgery from vertebrae c5 to c7.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 progressively worsening pain in his neck, shoulders and arms, weakness in his arms and legs, and numbness in some of his fingers.Severe pain and symptoms led to revision surgery on (b)(6) 2013.Patient continues to experience extreme neck pain, with pain radiating to his shoulders and arms, difficulty sleeping due to arm pain, and numbness in his fingers.¿.

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

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) 2012 the patient was pre-operatively diagnosed with cervical spondylosis stenosis and disc herniation at c5-c6 with upper extremity radiculopathy and weakness and underwent the following procedures: anterior cervical microscopic diskectomy, foraminotomy, and interbody arthrodesis c5-c6, c6-c7 with synthes machined allograft spacers, rhbmp-2 bone morphogenic protein, skyline anterior cervical plate.As per op-notes,¿ there was severe compression of the right foramen as well as the right side of the spinal canal due to a combination of disk and osteophyte.Following the decompression, the endplates were prepared.The space was measured at 8 mm and 8-mm machined allograft spacer was selected and a hole was drilled in the core of the spacer and a small piece of bone morphogenic protein sponge was placed within the confines of the spacer.The spacer was gently impacted into place under direct visualization.Pin at c7 was moved to c5.There were severe anterior osteophytes at c5-c6 and these were drilled off.Disk base was collapsed down to bone on bone.The inferior portion of the vertebral body of c5 was resected along with the superior portion of c6.¿ 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: 6208019
• MDR Text Key: 63359252
• Report Number: 1030489-2016-03586
• 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: 12/15/2017

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: 10/31/2012
• Device Catalogue Number: 7510050
• Device Lot Number: M111109AAI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2012
• 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