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

Catalog Number 7510100

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

Patient Problems Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Numbness (2415); Neck Pain (2433); Neck Stiffness (2434)

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) 2013, patient underwent posterolateral cervicothoracic fusion from vertebrae c3 to t2.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was placed outside a cage (in the posterolateral gutters).Allegedly, "patient's post-operative period was marked by a period of improvement, followed by progressively worsening neck and mid back pain, with radicular symptoms in her upper extremities.The patient continues to experience chronic pain in her neck, shoulders, hands and midback.She has limited range of motion in her neck, stiffness and spasms in her neck, and numbness in her arms and right hand.The patient also experiences difficulty speaking.".

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 the patient presented with following pre operative diagnosis: cervical stenosis with cervical myelopathy.The patient underwent the following procedures: c6 and c7 vertebral body corpectomy for spinal cord decompression; c4-c5 anterior cervical diskectomy and fusion for spinal canal decompression; anterior arthrodesis c4-t1; posterior segmental instrumentation c3 to t2 with lateral mass and pedicle screws; c3, c4, c5, c6 laminectomy and foraminotomy for spinal column nerve root compression; c7-t1, t1-t2 bilateral laminal foraminotomy for nerve root decompression; posterolateral arthrodesis c3-t2 with local lamina bone, corticocancellous bone and infused bone morphogenic protein; application and removal of mayfield cranial tongs; use of operating microscope for 2 level corpectomy; use of spinal cord monitoring.As per the operative notes, ¿at c7-t1 and t1-t2 i did bilateral laminal foraminotomies using a high-speed drill, decompressing the c8 and t1 nerve roots bilaterally.I next placed lordotic rods, secured the set screws and counter torqued.Irrigated the wound with 2 liters saline, decorticated posterolaterally from c3-t2 and placed local lamina bone, corticocancellous bone and a small packet of bone morphogenic protein posterolaterally for c3-t2 arthrodesis.Hemostasis was achieved.Final ap and lateral x-rays confirmed good hardware position, set screws counter torqued.¿ no intra operative 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: 6207998
• MDR Text Key: 63357911
• Report Number: 1030489-2016-03561
• 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: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Catalogue Number: 7510100
• Device Lot Number: M111304AAG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: 12/05/2016; 05/14/2018
• Supplement Dates FDA Received: 09/27/2017; 05/31/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2013
• 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