MAUDE Adverse Event Report: MEDTRONIC INFUSE BONE GRAFT

Model Number 7510800

Device Problem Device Expiration Issue (1216)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The surgical services staff identified variation in the printed expiration date for the infuse bone graft.The exterior package list expiration as year/month/day and the interior packaging of the graft list only year/month.There is a potential for use of expired graft if after the 1st of the month.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: INFUSE BONE GRAFT
• Manufacturer (Section D): MEDTRONIC; memphis TN 38132
• MDR Report Key: 5249598
• MDR Text Key: 32212863
• Report Number: MW5058080
• Device Sequence Number: 1
• Product Code: NEK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Model Number: 7510800
• Device Lot Number: M111401AAA
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1