TPLC - Total Product Life Cycle

• Device: dental stereotaxic instrument
• Regulation Description: Bone cutting instrument and accessories.
• 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	2
NAVIGATE SURGICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEOCIS, INC.
	SUBSTANTIALLY EQUIVALENT	6

MDR Year	MDR Reports	MDR Events
2021	11	11
2022	39	39
2023	15	15
2024	9	9
2025	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	33	33
Calibration Problem	15	15
Imprecision	11	11
Use of Device Problem	6	6
Failure to Calibrate	4	4
Positioning Problem	3	3
Off-Label Use	2	2
Unintended Movement	2	2
Overcorrection	1	1
Insufficient Information	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	42	42
Tooth Fracture	9	9
Laceration(s)	5	5
Failure of Implant	4	4
Low Oxygen Saturation	4	4
Insufficient Information	3	3
Sinus Perforation	2	2
Implant Pain	2	2
Abrasion	2	2
Skin Tears	2	2
Apnea	1	1
Blister	1	1
Nerve Damage	1	1
Bradycardia	1	1
Hemorrhage/Bleeding	1	1

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