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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
CLARONAV INC
  SUBSTANTIALLY EQUIVALENT 1
NAVIGATE SURGICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOCIS 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 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 20 20
Imprecision 11 11
Calibration Problem 8 8
Protective Measures Problem 2 2
Unintended Movement 2 2
Material Protrusion/Extrusion 1 1
Overcorrection 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Off-Label Use 1 1
Device Appears to Trigger Rejection 1 1
Difficult to Remove 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
Tooth Fracture 11 11
Low Oxygen Saturation 4 4
Skin Tears 2 2
Abrasion 2 2
Laceration(s) 2 2
Sinus Perforation 1 1
Injury 1 1
Apnea 1 1
Hemorrhage/Bleeding 1 1
Failure of Implant 1 1
Blister 1 1
Implant Pain 1 1
Insufficient Information 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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