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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)
Product CodeHBE
Regulation Number 882.4310
Device Class 2


Premarket Reviews
ManufacturerDecision
ADEOR MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP INC.
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMET MICOFIXATION
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 2
HUBLY INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC POWERED SURGICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NAKANISHI INC.
  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
2018 787 6375
2019 836 8856
2020 1025 10801
2021 1047 10601
2022 900 7868
2023 672 5099

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 2007 12358
Fracture 1114 1274
Flaked 772 33616
Break 474 553
Vibration 253 253
Detachment of Device or Device Component 192 264
Excessive Heating 159 159
Material Fragmentation 122 124
Material Twisted/Bent 82 961
Noise, Audible 82 82
No Apparent Adverse Event 68 68
Physical Resistance/Sticking 46 46
Fluid/Blood Leak 41 51
Mechanical Problem 39 39
Mechanical Jam 38 38
Separation Problem 36 36
Use of Device Problem 34 34
Device Remains Activated 32 32
Connection Problem 28 28
Smoking 26 26
Electrical /Electronic Property Problem 23 23
Dull, Blunt 20 20
Material Separation 19 19
Material Deformation 18 23
Defective Component 17 17
Material Disintegration 14 17
Complete Loss of Power 14 14
Material Integrity Problem 13 13
Bent 13 91
Adverse Event Without Identified Device or Use Problem 12 12
Self-Activation or Keying 11 11
Device-Device Incompatibility 10 10
Unintended Movement 10 10
Appropriate Term/Code Not Available 10 10
Intermittent Loss of Power 9 9
Difficult to Remove 9 9
Display or Visual Feedback Problem 9 9
Delivered as Unsterile Product 9 9
Entrapment of Device 8 8
Tear, Rip or Hole in Device Packaging 8 8
Packaging Problem 8 8
Insufficient Information 7 7
Computer Software Problem 7 7
Expiration Date Error 6 6
Loss of Power 6 6
Device Operates Differently Than Expected 6 6
Mechanics Altered 6 6
Naturally Worn 6 6
Fail-Safe Did Not Operate 5 5
Fitting Problem 5 5
Device Displays Incorrect Message 5 5
Intermittent Continuity 5 5
Misconnection 5 5
Disassembly 5 6
Unintended System Motion 5 5
Difficult to Insert 5 5
Leak/Splash 4 4
Image Display Error/Artifact 4 4
Corroded 4 54
Defective Device 4 4
Premature Separation 4 4
Environmental Particulates 4 4
Output Problem 4 4
Power Problem 3 3
Temperature Problem 3 3
Failure to Power Up 3 3
Unstable 3 3
Circuit Failure 3 3
Detachment Of Device Component 3 3
Degraded 3 3
Loose or Intermittent Connection 3 3
Peeled/Delaminated 3 3
Nonstandard Device 2 2
Device Emits Odor 2 2
Device Alarm System 2 2
Component Missing 2 2
Metal Shedding Debris 2 2
Improper or Incorrect Procedure or Method 2 2
Device Slipped 2 2
Communication or Transmission Problem 2 2
Blocked Connection 2 2
Scratched Material 2 2
Fail-Safe Problem 2 2
Device Dislodged or Dislocated 2 2
Operating System Becomes Nonfunctional 2 2
Output below Specifications 2 2
Intermittent Communication Failure 2 2
Inadequate Lubrication 2 26
Inaccurate Information 1 1
Material Protrusion/Extrusion 1 1
Electrical Shorting 1 1
Failure to Auto Stop 1 1
Difficult to Open or Remove Packaging Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Interrogation Problem 1 1
Inappropriate Tactile Prompt/Feedback 1 1
Device Fell 1 1
Material Split, Cut or Torn 1 1
Deformation Due to Compressive Stress 1 1
Sparking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2805 30562
No Consequences Or Impact To Patient 1090 7599
No Patient Involvement 888 17407
No Known Impact Or Consequence To Patient 547 4313
Insufficient Information 62 1503
Foreign Body In Patient 60 60
Device Embedded In Tissue or Plaque 60 60
Burn(s) 43 642
Unintended Radiation Exposure 26 26
No Information 24 134
Superficial (First Degree) Burn 24 376
Injury 21 21
Perforation 18 18
Hemorrhage/Bleeding 12 12
Radiation Exposure, Unintended 12 12
Chemical Exposure 10 10
Unspecified Tissue Injury 8 8
Burn, Thermal 6 107
Abrasion 5 5
Pain 5 5
Paresis 4 4
Spinal Cord Injury 4 4
Numbness 4 4
Blood Loss 4 4
No Code Available 3 3
Patient Problem/Medical Problem 2 2
Partial thickness (Second Degree) Burn 2 7
Tissue Damage 2 2
Hematoma 2 2
Swelling/ Edema 2 2
Failure of Implant 1 1
Oversedation 1 1
Cerebrospinal Fluid Leakage 1 1
Contusion 1 1
Death 1 1
Erythema 1 1
Bone Fracture(s) 1 1
Perforation of Vessels 1 1
Visual Impairment 1 1
Brain Injury 1 1
Pulmonary Dysfunction 1 1
Coma 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 Xomed, Inc. II Oct-21-2021
4 Stryker Instruments II Jul-28-2022
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