MAUDE Adverse Event Report: MEDTRONIC INFUSE BMP; BONE GRAFT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cyst(s) (1800); Osteolysis (2377)

Event Date 03/06/2015

Event Type  Injury  

Event Description

Patient had transforaminal interbody fusion with cage and bmp at two levels.Hospital; was (b)(6) center.At one of the two levels he has developed a cyst or osteolytic cavity in l5 approximately 12 x 12 mm approximately 1 year postop.

• Brand Name: INFUSE BMP
• Type of Device: BONE GRAFT
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 5681415
• MDR Text Key: 46084764
• Report Number: MW5062487
• Device Sequence Number: 1
• Product Code: MAX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 91