MAUDE MDR 8901744

MDR report key: 8901744
Report number: 1030489-2019-00908
Event key: 0
Event type: 3
Date of event: 2019-06-26
Date received: 2019-08-16
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 1
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: STACIE ZIEMBA
Address: 1800 PYRAMID PLACE MEMPHIS TN 38132 US
Phone: 901-901-9013
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	INFUSE BONE GRAFT	FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET	MEDTRONIC SOFAMOR DANEK USA, INC	NEK	NA	UNK	UNK				N	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-08-16	0	1. O

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00681490843782	INFUSE® Bone Graft	MEDTRONIC SOFAMOR DANEK, INC.	NEK	2014-09-23
00681490843805	INFUSE® Bone Graft	MEDTRONIC SOFAMOR DANEK, INC.	NEK	2014-09-23
00681490843812	INFUSE® Bone Graft	MEDTRONIC SOFAMOR DANEK, INC.	NEK	2014-09-23
00681490843829	INFUSE® Bone Graft	MEDTRONIC SOFAMOR DANEK, INC.	NEK	2014-09-23
00613994239518	INFUSE® Bone Graft	MEDTRONIC SOFAMOR DANEK, INC.	NEK	2014-09-23
00613994239525	INFUSE® Bone Graft	MEDTRONIC SOFAMOR DANEK, INC.	NEK	2014-09-23

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
PMA	P000058S098	NEK	INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device	Medtronic Sofamor Danek USA, Inc.	2026-03-19
PMA	P000058S097	NEK	INFUSE Bone Graft/Medtronic Interbody Fusion Device	Medtronic Sofamor Danek USA, Inc.	2026-02-24
PMA	P000058S096	NEK	Infuse Bone Graft	Medtronic Sofamor Danek USA, Inc.	2026-02-13
PMA	P000058S094	NEK	INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device	Medtronic Sofamor Danek USA, Inc.	2025-03-19
PMA	P000058S093	NEK	INFUSE™ Bone Graft/Medtronic Interbody Fusion Device	Medtronic Sofamor Danek USA, Inc.	2024-11-06