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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
CLARONAV
  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 190 193
2022 166 176
2023 200 209
2024 274 300
2025 210 244

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 255 264
Device Sensing Problem 165 168
Display or Visual Feedback Problem 153 153
Incorrect Interpretation of Signal 128 128
Application Program Problem 110 113
Incorrect, Inadequate or Imprecise Result or Readings 104 107
Human-Device Interface Problem 102 105
Imprecision 88 93
Communication or Transmission Problem 74 74
Mechanical Problem 63 64
Material Integrity Problem 53 55
Connection Problem 52 56
Environmental Compatibility Problem 49 49
Adverse Event Without Identified Device or Use Problem 48 48
Use of Device Problem 40 40
Incorrect Measurement 37 95
Computer Software Problem 27 28
Patient Device Interaction Problem 23 23
Unintended Application Program Shut Down 22 22
No Device Output 15 16
Unexpected Shutdown 14 14
Image Orientation Incorrect 12 12
Audible Prompt/Feedback Problem 11 11
Electrical /Electronic Property Problem 7 7
Insufficient Information 7 7
Output Problem 6 6
Detachment of Device or Device Component 6 6
Power Problem 6 6
Failure to Read Input Signal 5 5
Computer Operating System Problem 4 4
Electromagnetic Interference 4 4
Failure to Power Up 4 4
Data Problem 3 3
Overheating of Device 3 3
Delayed Program or Algorithm Execution 3 3
Smoking 3 3
Break 3 3
Mechanics Altered 2 2
Degraded 2 2
Material Fragmentation 2 2
Failure to Shut Off 2 2
Fracture 2 2
Component Missing 2 2
Labelling, Instructions for Use or Training Problem 1 1
Product Quality Problem 1 1
Material Separation 1 1
Noise, Audible 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Decreased Sensitivity 1 1
Failure to Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1036 1118
No Known Impact Or Consequence To Patient 108 108
No Patient Involvement 34 34
Cerebrospinal Fluid Leakage 21 21
Perforation of Vessels 7 7
Insufficient Information 5 8
Stroke/CVA 4 4
Hemorrhage/Bleeding 4 4
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
No Consequences Or Impact To Patient 1 1
Loss of Vision 1 1
Bacterial Infection 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 Integra LifeSciences Corp. (NeuroSciences) II Nov-04-2025
6 Stryker Leibinger GmbH & Co. KG II May-23-2024
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