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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device drills, burrs, trephines & accessories (simple, powered)
Regulation Description Powered simple cranial drills, burrs, trephines, and their accessories.
Product CodeHBE
Regulation Number 882.4310
Device Class 2


Premarket Reviews
ManufacturerDecision
AD-TECH MEDICAL INSTRUMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ADEOR MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP INC.
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREVATURE MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NAKANISHI INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 849 907
2017 848 2252
2018 787 6375
2019 836 8856
2020 1025 10801
2021 939 10494

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 1949 8023
Flaked 936 28105
Fracture 757 865
Break 710 852
Vibration 246 246
Detachment of Device or Device Component 133 169
Excessive Heating 103 103
Disassembly 94 106
Bent 86 267
Noise, Audible 84 84
Material Twisted/Bent 78 957
Material Fragmentation 77 79
Mechanical Problem 64 64
Device Operates Differently Than Expected 48 48
Physical Resistance/Sticking 34 34
Detachment Of Device Component 33 33
Smoking 32 32
Use of Device Problem 30 30
Fluid Leak 30 36
Device Inoperable 27 27
Defective Component 24 24
Connection Problem 24 24
Mechanical Jam 24 24
Temperature Problem 23 23
No Apparent Adverse Event 22 22
Material Separation 22 22
Separation Problem 21 21
Dull, Blunt 19 19
Naturally Worn 18 18
Device Remains Activated 17 17
Device Slipped 16 16
Material Deformation 16 16
Device Displays Incorrect Message 15 15
Leak/Splash 15 17
Self-Activation or Keying 14 14
Difficult to Remove 13 13
Unintended System Motion 11 11
Unstable 11 11
Component Missing 11 11
Corroded 11 61
Material Integrity Problem 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Electrical /Electronic Property Problem 10 10
Sticking 10 10
Display or Visual Feedback Problem 9 9
Loose or Intermittent Connection 9 9
Mechanics Altered 8 8
Defective Device 8 8
Unintended Movement 8 8
Insufficient Information 7 7
Device-Device Incompatibility 7 7
Packaging Problem 7 7
Computer Software Problem 7 7
Delivered as Unsterile Product 7 7
Difficult To Position 6 6
Loss of Power 6 6
Fitting Problem 6 6
Appropriate Term/Code Not Available 6 6
Complete Loss of Power 6 6
Misconnection 5 5
Difficult to Insert 5 5
Material Disintegration 5 6
Entrapment of Device 5 5
Image Display Error/Artifact 4 4
Peeled/Delaminated 4 4
Tear, Rip or Hole in Device Packaging 4 4
Metal Shedding Debris 4 4
Output Problem 4 4
Output below Specifications 3 3
Fail-Safe Problem 3 3
Intermittent Loss of Power 3 3
Power Problem 3 3
Premature Separation 3 3
Failure to Power Up 3 3
Failure To Adhere Or Bond 3 3
Intermittent Continuity 3 3
Component Falling 3 3
Degraded 3 3
Circuit Failure 3 3
Partial Blockage 2 2
Unintended Power Up 2 2
Component Incompatible 2 2
Disconnection 2 2
Nonstandard Device 2 2
Improper or Incorrect Procedure or Method 2 2
Incorrect Or Inadequate Test Results 2 2
Expiration Date Error 2 2
Inadequate Lubrication 2 26
Protective Measures Problem 2 2
Scratched Material 2 2
Intermittent Communication Failure 2 2
Failure to Auto Stop 2 2
Operating System Becomes Nonfunctional 2 2
Material Protrusion/Extrusion 2 2
Device Dislodged or Dislocated 2 2
Communication or Transmission Problem 2 2
Blocked Connection 2 2
Failure to Cut 2 2
Failure to Calibrate 1 1
Sparking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 1840 19339
No Consequences Or Impact To Patient 1411 8188
No Clinical Signs, Symptoms or Conditions 1218 17581
No Known Impact Or Consequence To Patient 906 4905
Device Embedded In Tissue or Plaque 54 54
Foreign Body In Patient 49 53
No Information 36 146
Burn(s) 30 189
Insufficient Information 23 345
Radiation Exposure, Unintended 21 21
Injury 21 21
Superficial (First Degree) Burn 19 217
No Code Available 18 18
Perforation 14 14
Unintended Radiation Exposure 12 12
Chemical Exposure 9 9
Burn, Thermal 6 107
Partial thickness (Second Degree) Burn 6 11
Abrasion 5 5
Hemorrhage/Bleeding 5 5
Blood Loss 4 4
Tissue Damage 3 3
Brain Injury 2 2
Pain 2 2
Cerebrospinal Fluid Leakage 2 2
Death 2 2
Patient Problem/Medical Problem 2 2
Coma 1 1
Needle Stick/Puncture 1 1
Unspecified Tissue Injury 1 1
Hematoma 1 1
Contusion 1 1
Hemorrhage, Subdural 1 1
Failure of Implant 1 1
Oversedation 1 1
Paresis 1 1
Sprain 1 1
Therapeutic Effects, Unexpected 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ad-Tech Medical Instrument Corporation II Jul-25-2018
2 Aesculap Implant Systems LLC II Feb-15-2018
3 Medtronic Sofamor Danek Usa, Inc - Dallas Distribution II Jun-28-2016
4 Medtronic Xomed, Inc. II Oct-21-2021
5 Stryker Instruments Div. of Stryker Corporation II Dec-21-2016
6 Stryker Instruments Div. of Stryker Corporation II Jul-19-2016
7 Stryker Instruments Div. of Stryker Corporation II Jul-14-2016
8 The Anspach Effort, Inc. II May-04-2017
9 The Anspach Effort, Inc. II Sep-16-2016
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