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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

MDR Year MDR Reports MDR Events
2020 100 100
2021 131 133
2022 229 229
2023 261 261
2024 368 368
2025 407 407

Device Problems MDRs with this Device Problem Events in those MDRs
Break 870 870
Vibration 496 496
Physical Resistance/Sticking 107 107
Mechanical Jam 72 72
Material Fragmentation 53 53
Material Separation 48 48
Connection Problem 27 27
Noise, Audible 19 19
Overheating of Device 13 13
Mechanical Problem 12 12
Failure to Cut 11 11
Use of Device Problem 10 10
Material Twisted/Bent 9 9
Device Markings/Labelling Problem 7 7
Output Problem 5 5
Fitting Problem 4 4
Defective Device 3 5
Unintended Movement 3 3
Difficult to Insert 3 3
Fracture 3 3
Material Deformation 2 2
Inadequacy of Device Shape and/or Size 2 2
Device-Device Incompatibility 2 2
Dull, Blunt 2 2
Smoking 1 1
Defective Component 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Contamination 1 1
Difficult to Remove 1 1
Contamination /Decontamination Problem 1 1
Failure to Power Up 1 1
Inability to Irrigate 1 1
Failure to Align 1 1
Collapse 1 1
Suction Failure 1 1
Blocked Connection 1 1
Mechanics Altered 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Misconnection 1 1
Crack 1 1
Detachment of Device or Device Component 1 1
Material Protrusion/Extrusion 1 1
No Apparent Adverse Event 1 1
Activation Problem 1 1
Off-Label Use 1 1
Failure to Disconnect 1 1
Intermittent Loss of Power 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1389 1389
No Consequences Or Impact To Patient 66 66
Insufficient Information 26 28
No Patient Involvement 11 11
Unintended Radiation Exposure 9 9
Unspecified Tissue Injury 6 6
Device Embedded In Tissue or Plaque 6 6
No Known Impact Or Consequence To Patient 4 4
Radiation Exposure, Unintended 3 3
Bone Fracture(s) 3 3
Foreign Body In Patient 3 3
Oversedation 2 2
Eye Injury 2 2
Superficial (First Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Xomed, Inc. II Sep-12-2024
2 Medtronic Xomed, Inc. II Oct-21-2021
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