MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK, INC. INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE

Catalog Number 7510400

Device Problem Break (1069)

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

Event Date 06/28/2017

Event Type  malfunction  

Event Description

The glass vial in the pack was found broken when opened.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK, INC.; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 6756511
• MDR Text Key: 81487582
• Report Number: 6756511
• Device Sequence Number: 1
• Product Code: MPW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 7510400
• Device Lot Number: M111613AAC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 50 YR
• Patient Weight: 59