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

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

Patient Problems Death (1802); Pain (1994)

Event Type  Death  

Event Description

It was reported that a patient was admitted to hospital in (b)(6) 2007 for unspecified reason.Eight days later, the patient underwent posterior cervical spinal fusion on the cervical region of his spine from vertebrae c2-c3 using rhbmp-2/acs.Patient's post-operative period was marked by progressive spinal, back and rib cage chronic pain and eventual diagnosis of multiple myeloma.In order to attempt to treat patient¿s cancer, a prolonged, extensive and painful course of medical treatments was necessitated, including, but not limited to chemotherapy treatments.The patient died from multiple myeloma and related complications.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2007, patient underwent following procedure: posterior cervical fusion, c2-3, posterior cervical instrumentation, c2-3; harvest of local iliac crest bone graft; use of rhbmp-2/acs; intraoperative spinal cord monitoring; for pre-op diagnosis of: unstable c2-3 injury.Indications: patient fell of surfboard and injured his cervical spine.Mri of lumbar spine did not showed any instability.Radiograph obtained in collar showed subluxation of 4.5mm.Per-op notes: ".There was excessive amount of motion between c2 and c3.This was more pronounced towards right side.The facets bilaterally were injured and were completely disrupted over right and partially disrupted over left.A high speed burr was used to decorticate the posterior element at c2 and c3.Rhbmp-2/acs had been prepped and this was laid over the c2-3 level and the cancellous autograft was placed on top of this.No 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4484794
• MDR Text Key: 21451268
• Report Number: 1030489-2015-00230
• 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
• Report Date: 03/14/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 02/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Death; Required Intervention