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

Model Number 7510100

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/07/2019

Event Type  malfunction  

Event Description

A medtronic bone graft package was opened for use in the operating room.Upon inspection of the sealed package, a small lizard-type creature was identified possibly of the gecko species.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 8319918
• MDR Text Key: 135522998
• Report Number: 8319918
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7510100
• Device Lot Number: M111806AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1