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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device motor, drill, pneumatic
Regulation Description Pneumatic cranial drill motor.
Product CodeHBB
Regulation Number 882.4370
Device Class 2

MDR Year MDR Reports MDR Events
2020 263 372
2021 260 419
2022 172 332
2023 180 306
2024 759 977
2025 735 811

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 831 1297
Detachment of Device or Device Component 604 639
No Apparent Adverse Event 194 194
Output below Specifications 179 179
Material Puncture/Hole 141 141
Difficult to Insert 104 104
Noise, Audible 89 89
Fluid/Blood Leak 88 414
Naturally Worn 83 83
Vibration 70 70
Break 66 65
Fracture 54 54
Loss of Power 50 50
Difficult to Remove 49 49
Physical Resistance/Sticking 46 47
Unintended System Motion 45 45
Material Twisted/Bent 43 43
Excessive Heating 40 40
Device Remains Activated 35 35
Complete Loss of Power 33 33
Corroded 31 31
Electrical /Electronic Property Problem 29 29
Burst Container or Vessel 25 36
Appropriate Term/Code Not Available 19 19
Leak/Splash 16 16
Fail-Safe Did Not Operate 16 16
Mechanical Jam 13 13
Unintended Power Up 12 20
Premature Separation 11 11
Smoking 10 10
Material Deformation 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Misconnection 10 10
Device Displays Incorrect Message 9 9
Material Rupture 9 9
Fail-Safe Problem 7 10
Material Fragmentation 6 6
Insufficient Information 5 5
Gas/Air Leak 4 4
Energy Output Problem 4 4
Device-Device Incompatibility 4 4
Degraded 3 3
Material Integrity Problem 3 3
Failure to Auto Stop 3 3
Mechanical Problem 3 3
Dull, Blunt 3 3
Device Contaminated During Manufacture or Shipping 3 3
Explosion 2 2
Device Reprocessing Problem 2 2
Defective Component 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2075 2899
No Consequences Or Impact To Patient 164 186
Insufficient Information 71 207
No Patient Involvement 35 120
Burn(s) 14 14
Chemical Exposure 13 13
Unintended Radiation Exposure 12 12
No Known Impact Or Consequence To Patient 11 11
Device Embedded In Tissue or Plaque 8 8
Perforation 7 7
Injury 6 6
Unspecified Tissue Injury 6 6
Cerebrospinal Fluid Leakage 6 6
Hearing Impairment 5 5
Unspecified Infection 5 5
Tissue Damage 5 5
Hemorrhage/Bleeding 5 5
Spinal Column Injury 4 4
Nerve Damage 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Tinnitus 3 3
Pain 2 2
Spinal Cord Injury 2 2
Muscle Weakness 1 1
Foreign Body In Patient 1 1
Oversedation 1 1
Intracranial Hemorrhage 1 1
Numbness 1 1
Laceration(s) 1 1
Awareness during Anaesthesia 1 1
Reaction 1 1
Partial thickness (Second Degree) Burn 1 3
Headache 1 1

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