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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


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 273 452
2017 203 477
2018 295 652
2019 284 722
2020 263 373
2021 110 180

Device Problems MDRs with this Device Problem Events in those MDRs
Output below Specifications 427 427
Leak/Splash 176 1005
Overheating of Device 140 357
Noise, Audible 91 91
Unintended System Motion 90 90
Material Puncture/Hole 79 79
Fluid Leak 75 337
Fail-Safe Problem 67 86
Break 57 55
Detachment of Device or Device Component 51 78
Device Abrasion From Instrument Or Another Object 47 47
Device Operates Differently Than Expected 36 36
No Apparent Adverse Event 27 27
Unintended Power Up 24 80
Device Inoperable 23 23
Vibration 22 22
Disassembly 20 29
Device Remains Activated 19 20
Mechanical Problem 17 17
Burst Container or Vessel 17 25
Mechanical Jam 16 16
Hole In Material 13 13
Partial Blockage 13 13
Detachment Of Device Component 11 11
Air Leak 11 11
Naturally Worn 11 11
Complete Loss of Power 10 10
Unintended Movement 10 18
Fracture 9 8
Difficult to Insert 8 8
Loss of Power 8 8
Physical Resistance/Sticking 8 9
Power Problem 8 8
Unexpected Shutdown 7 7
Excessive Heating 7 7
Material Rupture 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Device Slipped 6 6
Temperature Problem 6 6
Electrical /Electronic Property Problem 5 5
Defective Component 5 5
Sticking 5 7
Cut In Material 5 5
Defective Device 4 4
Failure to Auto Stop 4 4
Material Fragmentation 4 4
Bent 4 4
Self-Activation or Keying 4 4
Failure to Power Up 4 4
Difficult to Remove 4 4
Insufficient Information 4 4
Intermittent Loss of Power 3 3
Device Fell 3 3
Material Separation 3 3
Misconnection 3 3
Material Twisted/Bent 3 6
Failure of Device to Self-Test 3 3
Incorrect Or Inadequate Test Results 3 3
Obstruction of Flow 2 2
Physical Resistance 2 2
Malposition of Device 2 2
Connection Problem 2 2
Device Stops Intermittently 2 2
Device Operational Issue 2 2
Energy Output Problem 2 2
Migration or Expulsion of Device 2 4
Smoking 2 2
Appropriate Term/Code Not Available 2 2
Torn Material 2 2
Premature Separation 2 2
Pressure Problem 1 1
Protective Measures Problem 1 1
Positioning Problem 1 1
Ejection Problem 1 1
Intermittent Energy Output 1 1
Nonstandard Device 1 1
No Display/Image 1 1
Component Falling 1 4
Contamination 1 1
Corroded 1 1
Positioning Failure 1 1
Flaked 1 1
Loose or Intermittent Connection 1 1
Device Damaged by Another Device 1 1
Device Packaging Compromised 1 1
Failure to Shut Off 1 1
Gas Leak 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Mechanics Altered 1 1
No Fail-Safe Mechanism 1 1
Unstable 1 1
Component Missing 1 1
Metal Shedding Debris 1 1
Material Perforation 1 1
Activation, Positioning or SeparationProblem 1 1
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 521 841
No Patient Involvement 443 1281
No Known Impact Or Consequence To Patient 277 728
No Clinical Signs, Symptoms or Conditions 155 321
Perforation 12 12
Injury 11 11
Burn(s) 10 10
Hearing Impairment 10 10
Chemical Exposure 7 7
Device Embedded In Tissue or Plaque 7 7
No Information 6 92
Radiation Exposure, Unintended 6 6
Tissue Damage 6 6
Foreign Body In Patient 5 5
Cerebrospinal Fluid Leakage 5 5
Spinal Column Injury 4 4
Insufficient Information 4 4
Hemorrhage/Bleeding 4 4
Unspecified Infection 4 4
Nerve Damage 4 4
Death 3 3
Unspecified Tissue Injury 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Hematoma 2 2
No Code Available 2 2
Acoustic Trauma 2 3
Burn, Thermal 2 4
Reaction 1 1
Contusion 1 1
Headache 1 1
Internal Organ Perforation 1 1
Tinnitus 1 1
Laceration(s) 1 1
Not Applicable 1 1
Failure of Implant 1 1
Hearing Loss 1 1
Erythema 1 1
Fatigue 1 1
Sprain 1 1
Superficial (First Degree) Burn 1 7

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Feb-15-2018
2 Medtronic Sofamor Danek Usa, Inc - Dallas Distribution II May-04-2016
3 Stryker Instruments Div. of Stryker Corporation II Jun-09-2016
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