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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
Regulation Description 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 4
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
2020 161 161
2021 190 190
2022 167 167
2023 210 210
2024 278 302
2025 115 136

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 247 247
Device Sensing Problem 156 156
Display or Visual Feedback Problem 133 133
Incorrect Interpretation of Signal 128 128
Human-Device Interface Problem 103 103
Application Program Problem 102 102
Imprecision 88 88
Incorrect, Inadequate or Imprecise Result or Readings 75 75
Mechanical Problem 58 58
Communication or Transmission Problem 58 58
Material Integrity Problem 53 53
Connection Problem 50 50
Environmental Compatibility Problem 49 49
Adverse Event Without Identified Device or Use Problem 46 46
Use of Device Problem 31 31
Incorrect Measurement 27 72
Computer Software Problem 25 25
Patient Device Interaction Problem 23 23
Unintended Application Program Shut Down 19 19
Unexpected Shutdown 13 13
No Device Output 12 12
Image Orientation Incorrect 12 12
Audible Prompt/Feedback Problem 7 7
Electrical /Electronic Property Problem 7 7
Insufficient Information 7 7
Detachment of Device or Device Component 6 6
Output Problem 5 5
Computer Operating System Problem 4 4
Power Problem 4 4
Electromagnetic Interference 4 4
Failure to Read Input Signal 3 3
Delayed Program or Algorithm Execution 3 3
Data Problem 3 3
Overheating of Device 2 2
Smoking 2 2
Mechanics Altered 2 2
Degraded 2 2
Material Fragmentation 2 2
Failure to Shut Off 2 2
Fracture 2 2
Failure to Power Up 2 2
Break 2 2
Component Missing 2 2
Noise, Audible 1 1
Therapy Delivered to Incorrect Body Area 1 1
Failure to Capture 1 1
Premature Activation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Product Quality Problem 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 958 1003
No Known Impact Or Consequence To Patient 108 108
No Patient Involvement 34 34
Cerebrospinal Fluid Leakage 19 19
Perforation of Vessels 7 7
Stroke/CVA 4 4
Hemorrhage/Bleeding 4 4
Insufficient Information 3 6
Unspecified Tissue Injury 3 3
Unspecified Nervous System Problem 2 2
Pain 2 2
Hypoxia 2 2
Headache 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hypoventilation 1 1
Electric Shock 1 1
Fatigue 1 1
Hematoma 1 1
Obstruction/Occlusion 1 1
Cardiac Arrest 1 1
Incontinence 1 1
Post Operative Wound Infection 1 1
Burn(s) 1 1
Burning Sensation 1 1
Erythema 1 1
Urinary Retention 1 1
Discomfort 1 1
Alteration in Body Temperature 1 1
Visual Impairment 1 1
Anaphylactic Shock 1 1
Calcium Deposits/Calcification 1 1
Swelling/ Edema 1 1
Bacterial Infection 1 1
Loss of Vision 1 1
No Consequences Or Impact To Patient 1 1
Urinary Frequency 1 1
Low Blood Pressure/ Hypotension 1 1
Unintended Extubation 1 1
Urinary Tract Infection 1 1
Ambulation Difficulties 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 Integra LifeSciences Corp. II Aug-05-2024
5 Stryker Leibinger GmbH & Co. KG II May-23-2024
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