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

Catalog Number 7510200

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

Patient Problems Ossification (1428); Dysphagia/ Odynophagia (1815); Inflammation (1932); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Respiratory Distress (2045); Weakness (2145); Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the patient underwent an anterior cervical discectomy and fusion using rhbmp-2/acs.The patient's post-operative period was marked by severe pain.Following the surgery the patient suffered from autonomic neuropathy, small fiber neuropathy, peripheral neuropathy, muscle atrophy and nerve damage, inflammatory reactions, chronic radiculitis, sterility, osteolysis (bone resorption), displacement or migration of the spacer cage, pseudoarthrosis, dysphagia, difficulty breathing, difficulty gripping and holding items, and chronic pain.The patient now suffers from bone overgrowth causing nerve compression, chronic pain and radiculitis, and emotional distress and mental anguish.

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.

Manufacturer Narrative

Event Description

It was reported that the patient underwent an anterior cervical discectomy fusion procedure at c3-6 using rhbmp-2/acs.The patient's post-operative period was marked by an acute inflammatory reaction.

Event Description

It was reported that on (b)(6) 2009: the patient presented with cervical pain.Cervical radiculopathy.Cervical disk herniation at c3-4, c4-5 and c5-6.The patient underwent the following procedures: anterior cervical discectomy at c3-4, c4-5 and c5-6, approached from the patient's right side.Structural allograft fusion c3-4, c4-5, and c5-6.Arthrodesis c3-4, c4-5, and c5-6.Anterior cervical plating c3-c6, bone morphogenic protein.Placement of philadelphia collar.The post-op diagnosis: cervical pain.Cervical radiculopathy.Cervical disk herniation at c3-4, c4-5 and c5-6.Cervical instability.Bony foraminal stenosis c5-6 bilaterally.As per-op notes, "the c4-5 disk space was identified using fluoroscopy.Diskectomy was performed at c4-5.Identical procedure was performed at c5-6 and at c3-4.All the levels required drilling to remove the remainder of the disk material and to prepare the endplates for fusion.The posterior longitudinal ligament at c3-4 and c5-6 both had been violated by extruded disk fragments, which were removed.At c3-4, there was some bony osteophytic component but the largest component of the compression of the spinal cord was the disk fragment that herniated.The bony osteophytic components as well as soft tissue components were removed.Identical procedures were performed at c4-5 and c5-6.Once all the three levels were decompressed, they were irrigated and hemostasis was achieved.A small 2 to 4 mm fragment of rhbmp-2/acs was placed in the small circular space of each of the bone grafts, and that was placed at each level.Once the 6 mm bony structural allografts were placed at each level, they were tamped into place, and the cervical traction was removed."no patient complications were reported.On (b)(6) 2009: the patient was discharged.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3661568
• MDR Text Key: 4316529
• Report Number: 1030489-2014-01313
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2012
• Device Catalogue Number: 7510200
• Device Lot Number: M110805AAB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/24/2009
• 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