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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 38 74

Device Problems MDRs with this Device Problem Events in those MDRs
Output below Specifications 393 393
Leak/Splash 170 999
Overheating of Device 135 342
Unintended System Motion 90 90
Noise, Audible 90 90
Fluid Leak 72 311
Material Puncture/Hole 68 68
Fail-Safe Problem 67 86
Break 53 52
Device Abrasion From Instrument Or Another Object 47 47
Detachment of Device or Device Component 45 70
Device Operates Differently Than Expected 36 36
Motor(s) 33 33
Unintended Power Up 24 80
No Apparent Adverse Event 24 24
Device Inoperable 23 23
Disassembly 20 29
Device Remains Activated 19 20
Vibration 17 17
Mechanical Problem 17 17
Burst Container or Vessel 15 23
Mechanical Jam 14 14
Hose 13 13
Partial Blockage 13 13
Hole In Material 13 13
Detachment Of Device Component 11 11
Air Leak 11 11
Naturally Worn 11 11
Unintended Movement 9 17
Bearings 9 9
Fracture 9 9
Difficult to Insert 8 8
Loss of Power 8 8
Power Problem 8 8
Handpiece 8 8
Device Subassembly 7 7
Physical Resistance/Sticking 7 8
Unexpected Shutdown 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Material Rupture 7 7
Device Slipped 6 6
Temperature Problem 6 6
Complete Loss of Power 6 6
Defective Component 5 5
Sticking 5 7
Cut In Material 5 5
Electrical /Electronic Property Problem 5 5
Material Fragmentation 4 4
Housing 4 4
Bent 4 4
Defective Device 4 4
Failure to Auto Stop 4 4
Self-Activation or Keying 4 4
Failure to Power Up 4 4
Difficult to Remove 4 4
Tip 4 4
Excessive Heating 4 4
Knife 4 4
Insufficient Information 3 3
Intermittent Loss of Power 3 3
Material Twisted/Bent 3 6
Failure of Device to Self-Test 3 3
Material Separation 3 3
Incorrect Or Inadequate Test Results 3 3
Misconnection 3 3
Energy Output Problem 2 2
Migration or Expulsion of Device 2 4
Lock 2 2
Valve(s) 2 2
Obstruction of Flow 2 2
Physical Resistance 2 2
Malposition of Device 2 2
Connection Problem 2 2
Device Operational Issue 2 2
Smoking 2 2
Device Stops Intermittently 2 2
Torn Material 2 2
Connector Pin 2 2
Device Fell 2 2
Appropriate Term/Code Not Available 2 2
Switch, Push Button 2 2
Premature Separation 2 2
Locking Mechanism 1 1
Ejection Problem 1 1
Intermittent Energy Output 1 1
Pressure Problem 1 1
Protective Measures Problem 1 1
Positioning 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
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

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 79 170
Perforation 12 12
Injury 11 11
Hearing Impairment 10 10
Burn(s) 9 9
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
Hemorrhage/Bleeding 4 4
Unspecified Infection 4 4
Nerve Damage 4 4
Death 3 3
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Hematoma 2 2
Acoustic Trauma 2 3
Burn, Thermal 2 4
No Code Available 2 2
Unspecified Tissue Injury 2 2
Not Applicable 1 1
Reaction 1 1
Contusion 1 1
Headache 1 1
Internal Organ Perforation 1 1
Tinnitus 1 1
Laceration(s) 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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