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TPLC
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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
NAVIGATE SURGICAL TECHNOLOGIES INC.
SUBSTANTIALLY EQUIVALENT
1
NEOCIS INC.
SUBSTANTIALLY EQUIVALENT
11
X-NAV TECHNOLOGIES, LLC
SUBSTANTIALLY EQUIVALENT
1
X-NAV TECHNOLOGIES,LLC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
3
3
2021
11
11
2022
39
39
2023
5
5
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
Positioning Problem
3
3
Protective Measures Problem
2
2
Unintended Movement
2
2
Inadequate User Interface
1
1
Material Protrusion/Extrusion
1
1
Overcorrection
1
1
Loose or Intermittent Connection
1
1
Incorrect Measurement
1
1
Mechanical Problem
1
1
Off-Label Use
1
1
Product Quality Problem
1
1
Device Appears to Trigger Rejection
1
1
Difficult to Remove
1
1
Use of Device Problem
1
1
Failure to Calibrate
1
1
Defective Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
26
26
Tooth Fracture
11
11
Low Oxygen Saturation
4
4
Insufficient Information
3
3
Laceration(s)
3
3
Abrasion
2
2
Skin Tears
2
2
Sinus Perforation
1
1
Hemorrhage/Bleeding
1
1
Apnea
1
1
Blister
1
1
Injury
1
1
Implant Pain
1
1
Failure of Implant
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Neocis Inc.
II
Jul-16-2020
2
Neocis Inc.
II
Nov-21-2019
3
Neocis, Inc.
II
Jan-26-2021
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