TPLC - Total Product Life Cycle

• Device: spinal vertebral body replacement device - cervical
• Definition: Vertebral body replacement in the cervical spine.
• Product Code: PLR
• Regulation Number: 888.3060
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AESCULAP IMPLANTS SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ASTURA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
BRIGHT SPINE
	SUBSTANTIALLY EQUIVALENT	2
CARDINAL SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
CMF MEDICON SURGICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
COLIGNE, AG
	SUBSTANTIALLY EQUIVALENT	1
K2M, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	1
MIRUS, LLC
	SUBSTANTIALLY EQUIVALENT	1
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
OMNIA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
STRYKER SPINE
	SUBSTANTIALLY EQUIVALENT	1
ZAVATION MEDICAL PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2018	1	1
2019	1	1
2020	2	2
2021	4	4
2022	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	3	3
Insufficient Information	3	3
Migration	2	2
Mechanics Altered	2	2
Device Misassembled During Manufacturing /Shipping	1	1
Packaging Problem	1	1
Activation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5	5
Dysphagia/ Odynophagia	2	2
Pain	1	1
Neck Pain	1	1
Respiratory Failure	1	1
No Known Impact Or Consequence To Patient	1	1
Swelling/ Edema	1	1
Abdominal Pain	1	1
Arthritis	1	1