TPLC - Total Product Life Cycle

• Device: cement obturator
• Regulation Description: Surgical mesh.
• Product Code: LZN
• Regulation Number: 878.3300
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
HOWMEDICA OSTEONICS, DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	11	11
2021	12	12
2022	6	6
2023	13	13
2024	7	7
2025	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	20	20
Patient Device Interaction Problem	13	13
Adverse Event Without Identified Device or Use Problem	10	10
Delivered as Unsterile Product	6	6
Fracture	4	4
Leak/Splash	3	3
Break	3	3
Tear, Rip or Hole in Device Packaging	3	3
Entrapment of Device	2	2
Improper or Incorrect Procedure or Method	2	2
Crack	1	1
Degraded	1	1
Shipping Damage or Problem	1	1
Device Handling Problem	1	1
Migration	1	1
Osseointegration Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Osteolysis	22	22
No Clinical Signs, Symptoms or Conditions	12	12
Pain	6	6
Failure of Implant	4	4
Loss of Range of Motion	4	4
Swelling/ Edema	4	4
Unspecified Infection	3	3
Implant Pain	3	3
Insufficient Information	3	3
Bone Fracture(s)	2	2
Device Embedded In Tissue or Plaque	2	2
Inadequate Osseointegration	1	1
No Code Available	1	1
Metal Related Pathology	1	1
Inflammation	1	1
Cardiac Arrest	1	1
Discomfort	1	1
Bacterial Infection	1	1
No Consequences Or Impact To Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Depuy Ireland UC	II	Jan-12-2023
2	Stryker Corporation	II	Sep-19-2023