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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bur, ear, nose and throat
Regulation Description Ear, nose, and throat bur.
Product CodeEQJ
Regulation Number 874.4140
Device Class 1


Premarket Reviews
ManufacturerDecision
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 95 95
2017 118 118
2018 204 204
2019 129 129
2020 100 100
2021 95 95

Device Problems MDRs with this Device Problem Events in those MDRs
Break 282 282
Material Fragmentation 180 180
Material Separation 134 134
Vibration 113 113
Overheating of Device 30 30
Mechanical Jam 15 15
Use of Device Problem 14 14
Adverse Event Without Identified Device or Use Problem 11 11
Connection Problem 9 9
Device Markings/Labelling Problem 9 9
Unintended System Motion 5 5
Inability to Irrigate 5 5
Contamination /Decontamination Problem 5 5
Mechanical Problem 5 5
Output Problem 5 5
Stretched 4 4
Fracture 3 3
Complete Blockage 3 3
Noise, Audible 3 3
Obstruction of Flow 3 3
Material Twisted/Bent 3 3
Unintended Movement 3 3
Physical Resistance/Sticking 3 3
Loose or Intermittent Connection 3 3
Leak/Splash 2 2
Thermal Decomposition of Device 2 2
Detachment Of Device Component 2 2
Component Falling 2 2
Unstable 2 2
Detachment of Device or Device Component 2 2
Device Operates Differently Than Expected 2 2
No Apparent Adverse Event 2 2
Failure to Power Up 2 2
Off-Label Use 1 1
Smoking 1 1
Metal Shedding Debris 1 1
Suction Problem 1 1
Display or Visual Feedback Problem 1 1
Unintended Ejection 1 1
Device Emits Odor 1 1
No Device Output 1 1
Intermittent Loss of Power 1 1
Activation Problem 1 1
Defective Device 1 1
Blocked Connection 1 1
Contamination 1 1
Flaked 1 1
Misconnection 1 1
Self-Activation or Keying 1 1
Device Inoperable 1 1
Fitting Problem 1 1
Dull, Blunt 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 474 474
No Clinical Signs, Symptoms or Conditions 121 121
No Known Impact Or Consequence To Patient 112 112
No Patient Involvement 21 21
Radiation Exposure, Unintended 16 16
Device Embedded In Tissue or Plaque 9 9
Foreign Body In Patient 9 9
Burn(s) 8 8
Abrasion 5 5
Bone Fracture(s) 3 3
Burn, Thermal 3 3
Eye Injury 2 2
No Information 2 2
Cerebrospinal Fluid Leakage 2 2
Hearing Impairment 2 2
Oversedation 2 2
Unintended Radiation Exposure 2 2
Insufficient Information 1 1
Partial thickness (Second Degree) Burn 1 1
Vertigo 1 1
No Code Available 1 1
Unspecified Tissue Injury 1 1
Hemorrhage/Bleeding 1 1
Nerve Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Gyrus ACMI, Inc. II Mar-20-2018
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