INFUSE BONE GRAFT 7510800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2019-08-27 for INFUSE BONE GRAFT 7510800 manufactured by Medtronic Sofamor Danek Usa, Inc.

MAUDE Entry Details

• Report Number: 1030489-2019-00945
• MDR Report Key: 8933789
• Report Source: CONSUMER,FOREIGN,HEALTH PROFE
• Date Received: 2019-08-27
• Date of Report: 2019-11-27
• Date Mfgr Received: 2019-10-28
• Device Manufacturer Date: 2013-05-17
• Date Added to Maude: 2019-08-27
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: STACIE ZIEMBA
• Manufacturer Street: 1800 PYRAMID PLACE
• Manufacturer City: MEMPHIS TN 38132
• Manufacturer Country: US
• Manufacturer Postal: 38132
• Manufacturer Phone: 9013963133
• Manufacturer G1: MEDTRONIC SOFAMOR DANEK USA, INC
• Manufacturer Street: 4340 SWINEA RD
• Manufacturer City: MEMPHIS TN 38118
• Manufacturer Country: US
• Manufacturer Postal Code: 38118
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: INFUSE BONE GRAFT
• Generic Name: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Product Code: NEK
• Date Received: 2019-08-27
• Model Number: NA
• Catalog Number: 7510800
• Lot Number: M111202AAA
• Device Expiration Date: 2015-08-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
• Manufacturer Address: 4340 SWINEA RD MEMPHIS TN 38118 US 38118

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2019-08-27