TPLC - Total Product Life Cycle

• Device: growing rod system
• Definition: Stabilization or correction of spinal deformities without the use of fusion.
• Product Code: PGM
• Regulation Number: 888.3070
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
K2M, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	1
MEDOS SARL
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER BIOMET SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	5	5
2015	1	1
2016	9	9
2017	4	4
2018	1	1
2020	1	1
2022	5	5
2023	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	13	13
Adverse Event Without Identified Device or Use Problem	6	6
Migration or Expulsion of Device	3	3
Loose or Intermittent Connection	3	3
Fracture	2	2
Material Twisted/Bent	2	2
Malposition of Device	2	2
Patient-Device Incompatibility	1	1
Migration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	10	10
No Information	5	5
Pain	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Clinical Signs, Symptoms or Conditions	2	2
No Known Impact Or Consequence To Patient	2	2
Unspecified Infection	1	1
High Blood Pressure/ Hypertension	1	1
Death	1	1
Necrosis	1	1
Inflammation	1	1
Blood Loss	1	1
Incontinence	1	1
Spinal Column Injury	1	1
Skin Discoloration	1	1
Unspecified Nervous System Problem	1	1
Weakness	1	1
Paralysis	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Numbness	1	1
Nerve Damage	1	1
Laceration(s)	1	1
Bacterial Infection	1	1
Skin Burning Sensation	1	1