MAUDE MDR 2122175

MDR report key: 2122175
Report number: 2242816-2011-00065
Event key: 0
Event type: 3
Date of event: 2011-05-11
Date received: 2011-06-13
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 1
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Contact: ART KAUFMAN
Address: 100 INTERPACE PARKWAY PARSIPPANY 07054 US
Phone: 973-973-9732
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	OSTEOGEN	IMPLANTABLE BONE STIMULATOR	EBI, LLC	LOE		10-1320M					N	R

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2011-06-13	0	1. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT PATIENT COMPLAINED OF PAIN AND SWELLING OF LEG. A REVISION SURGERY WAS CONDUCTED AT WHICH RADIO-OPAQUE MATERIAL WAS FOUND AROUND THE BATTERY OF THE IMPLANTED DEVICE.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00812301020010	EBI OsteoGen Implantable Bone Growth Stimulator	EBI, LLC	LOE	2014-09-19
00812301020027	EBI OsteoGen™ Implantable Bone Growth Stimulator	EBI, LLC	LOE	2014-09-19
00812301020034	EBI OsteoGen™ Implantable Bone Growth Stimulator	EBI, LLC	LOE	2014-09-19
00812301020041	EBI OsteoGen™ Implantable Bone Growth Stimulator	EBI, LLC	LOE	2014-09-19
00812301020058	EBI OsteoGen™ Implantable Bone Growth Stimulator	EBI, LLC	LOE	2014-09-19
00812301020065	EBI OsteoGen™ Implantable Bone Growth Stimulator	EBI, LLC	LOE	2014-09-19
00812301020072	EBI OsteoGen™ Implantable Bone Growth Stimulator	EBI, LLC	LOE	2014-09-19
00812301020089	SpF XL IIb Implantable Spinal Fusion Stimulator	EBI, LLC	LOE	2014-09-19
00812301020096	SpF®-XL IIb Implantable Spinal Fusion Stimulator	EBI, LLC	LOE	2014-09-19
00812301020102	EBI OsteoGen™ Implantable Bone Growth Stimulator	EBI, LLC	LOE	2014-09-19
00812301020119	EBI OsteoGen™ Implantable Bone Growth Stimulator	EBI, LLC	LOE	2014-09-19
00812301020126	SpF®-PLUS-Mini (60 uA/M)	EBI, LLC	LOE	2014-09-19
00812301020133	SpF®-PLUS-Mini (60 uA/W)	EBI, LLC	LOE	2014-09-19

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
PMA	P850035S059	LOE	SpF® Implantable Spinal Fusion Stimulators	Ahp Eos Buyer, Inc.	2024-09-20
PMA	P850035S058	LOE	SpF® Implantable Spinal Fusion Stimulators	Ahp Eos Buyer, Inc.	2022-11-23
PMA	P790005S069	LOE	EBI OsteoGen® Implantable Bone Growth Stimulators	Ahp Eos Buyer, Inc.	2022-11-23
PMA	P850035S057	LOE	SpF Implantable Spinal Fusion Stimulators	Ahp Eos Buyer, Inc.	2022-08-25
PMA	P790005S068	LOE	EBI OsteoGen™ Implantable Bone Growth Stimulators	Ahp Eos Buyer, Inc.	2022-08-25