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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ear, nose, and throat stereotaxic instrument
Definition Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.
Product CodePGW
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCLARENT, INC.
  SUBSTANTIALLY EQUIVALENT 5
BIOSENSE WEBSTER
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 1
FIAGON GMBH
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC NAVIGATION INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STRYKER ENT
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 247 247
2020 161 161
2021 190 190
2022 167 167
2023 210 210
2024 110 110

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 225 225
Human-Device Interface Problem 184 184
Imprecision 136 136
Device Sensing Problem 105 105
Incorrect Interpretation of Signal 97 97
Display or Visual Feedback Problem 96 96
Mechanical Problem 78 78
Material Integrity Problem 67 67
Environmental Compatibility Problem 56 56
Connection Problem 49 49
Application Program Problem 44 44
Adverse Event Without Identified Device or Use Problem 43 43
Communication or Transmission Problem 28 28
Incorrect, Inadequate or Imprecise Result or Readings 25 25
Output Problem 25 25
Computer Software Problem 22 22
Incorrect Measurement 14 14
Patient Device Interaction Problem 12 12
Image Orientation Incorrect 11 11
Image Display Error/Artifact 10 10
Unexpected Shutdown 10 10
Use of Device Problem 9 9
Insufficient Information 7 7
Calibration Problem 5 5
Detachment of Device or Device Component 5 5
Computer Operating System Problem 4 4
Electromagnetic Interference 4 4
Electrical /Electronic Property Problem 4 4
No Device Output 4 4
Unintended Application Program Shut Down 4 4
Audible Prompt/Feedback Problem 3 3
Data Problem 2 2
Smoking 2 2
Material Separation 1 1
Failure to Read Input Signal 1 1
Installation-Related Problem 1 1
Excessive Cooling 1 1
Failure to Shut Off 1 1
Overheating of Device 1 1
Failure to Power Up 1 1
Fire 1 1
Fracture 1 1
Material Fragmentation 1 1
Break 1 1
Insufficient Cooling 1 1
Degraded 1 1
Delayed Program or Algorithm Execution 1 1
Excessive Heating 1 1
Power Problem 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 687 687
No Known Impact Or Consequence To Patient 280 280
No Patient Involvement 91 91
No Consequences Or Impact To Patient 16 16
Cerebrospinal Fluid Leakage 10 10
Perforation of Vessels 7 7
Stroke/CVA 4 4
Hemorrhage/Bleeding 4 4
Unspecified Tissue Injury 3 3
Unspecified Nervous System Problem 2 2
Tissue Damage 2 2
Headache 2 2
Complaint, Ill-Defined 2 2
Iatrogenic Source 1 1
Visual Impairment 1 1
Loss of Vision 1 1
Hematoma 1 1
Inflammation 1 1
Pain 1 1
Swelling 1 1
Erythema 1 1
Adhesion(s) 1 1
Burn(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Acclarent, Inc. II Oct-20-2023
2 Acclarent, Inc. II Dec-22-2021
3 Acclarent, Inc. II Jan-19-2020
4 Stryker Leibinger GmbH & Co. KG II May-23-2024
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