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 Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on: (b)(6) 2010: the patient presented with c3 through c6 stenosis with cord compression and myelopathy.The patient underwent the following procedures: c3 through c6 bilateral decompressive laminectomy and fusion with lateral mass screws and right-sided c5-6 foraminotomy.As per the operative notes,¿ the bone obtained was carefully morcellated and freed from soft tissue in order to use it for the subsequent fusion.With adequate decompression of the spinal cord, attention was turned towards foraminotomy of c5-6 on the right side.Soft tissue bleeding was controlled with bipolar cautery and once this was satisfactory the entire surgical site was irrigated with warm saline.Bone graft and rhbmp2/acs was placed along the lateral gutters in contact with bone, which had been previously been decorticated with a small burr.All retractors were then removed allowing tissues to come back together.¿ 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7661821
• MDR Text Key: 113156274
• Report Number: 1030489-2018-00948
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843805
• UDI-Public: 00681490843805
• 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
• Report Date: 07/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2011
• Device Catalogue Number: 7510400
• Device Lot Number: M110805AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2009
• 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