TPLC - Total Product Life Cycle

• Device: system, facet screw spinal device
• Product Code: MRW
• Device Class: Unclassified

Premarket Reviews
Manufacturer	Decision
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
AMENDIA, INC.
	SUBSTANTIALLY EQUIVALENT	2
APOLLO SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
CHOICE SPINE, LP
	SUBSTANTIALLY EQUIVALENT	1
CUSTOM SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIO MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
FACET-LINK, INC.
	SUBSTANTIALLY EQUIVALENT	2
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
HUVEXEL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
INTERVENTIONAL SPINE, INC.
	SE - WITH LIMITATIONS	1
K&J CONSULTING CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
LANX, INC.
	SUBSTANTIALLY EQUIVALENT	1
LDR SPINE USA
	SUBSTANTIALLY EQUIVALENT	1
LDR SPINE USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SPINE LLC.
	SUBSTANTIALLY EQUIVALENT	1
NEUROSTRUCTURES, LLC
	SUBSTANTIALLY EQUIVALENT	1
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
OSTEOMED L.P.
	SUBSTANTIALLY EQUIVALENT	1
PROVIDENCE MEDICAL TECHNOLOGY, INC
	SUBSTANTIALLY EQUIVALENT	3
PROVIDENCE MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	2
SEASPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPECTRUM SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINAL USA
	SUBSTANTIALLY EQUIVALENT	1
SPINE WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINEOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
SURGENTEC, LLC
	SUBSTANTIALLY EQUIVALENT	2
U&I CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
X-SPINE SYSTEMS, INC
	SUBSTANTIALLY EQUIVALENT	1
X-SPINE SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	1	1
2015	2	2
2016	1	1
2017	4	4
2018	4	4
2021	1	1
2023	1	1
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	6	6
Adverse Event Without Identified Device or Use Problem	5	5
Positioning Problem	1	1
Device Handling Problem	1	1
Migration	1	1
Material Fragmentation	1	1
Loose or Intermittent Connection	1	1
Migration or Expulsion of Device	1	1
Misassembled	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	4	4
No Consequences Or Impact To Patient	3	3
Insufficient Information	2	2
Injury	2	2
Not Applicable	1	1
No Information	1	1
No Code Available	1	1
Spinal Column Injury	1	1
Ossification	1	1
Unspecified Infection	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Halo	1	1
Stenosis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Interventional Spine Inc	II	Aug-18-2011
2	Medtronic Sofamor Danek USA, Inc	II	Jun-04-2021
3	Osteomed, Lp	II	Oct-04-2011