TPLC - Total Product Life Cycle

• Device: dental stereotaxic instrument
• Definition: To facilitate dental implant placement in patients that are partially endentulous or edentulous.
• Product Code: PLV
• Regulation Number: 872.4120
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
CLARONAV INC
	SUBSTANTIALLY EQUIVALENT	1
CLARONAV INC.
	SUBSTANTIALLY EQUIVALENT	1
NAVIGATE SURGICAL TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1
NEOCIS INC.
	SUBSTANTIALLY EQUIVALENT	9
X-NAV TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
X-NAV TECHNOLOGIES,LLC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	11	11
2022	39	39
2023	9	9
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	25	25
Imprecision	11	11
Calibration Problem	9	9
Use of Device Problem	4	4
Positioning Problem	3	3
Unintended Movement	2	2
Failure to Calibrate	2	2
Off-Label Use	1	1
Overcorrection	1	1
Defective Device	1	1
Difficult to Remove	1	1
Incorrect Measurement	1	1
Product Quality Problem	1	1
Material Protrusion/Extrusion	1	1
Device Appears to Trigger Rejection	1	1
Loose or Intermittent Connection	1	1
Improper or Incorrect Procedure or Method	1	1
Inadequate User Interface	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	31	31
Tooth Fracture	9	9
Low Oxygen Saturation	4	4
Insufficient Information	3	3
Laceration(s)	3	3
Abrasion	2	2
Skin Tears	2	2
Apnea	1	1
Failure of Implant	1	1
Sinus Perforation	1	1
Implant Pain	1	1
Blister	1	1
Hemorrhage/Bleeding	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Neocis Inc.	II	Jul-16-2020
2	Neocis, Inc.	II	Jan-26-2021