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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
ADEOR MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MICOFIXATION
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 2
HUBLY INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC POWERED SURGICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
NAKANISHI INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SURGIFY MEDICAL OY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1025 10801
2021 1047 10601
2022 900 7868
2023 948 7089
2024 1150 7142
2025 175 1423

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 2003 16033
Fracture 1315 1541
Flaked 614 25288
Vibration 270 270
Break 223 229
Detachment of Device or Device Component 195 321
Excessive Heating 177 177
Material Fragmentation 160 160
Noise, Audible 98 98
No Apparent Adverse Event 93 93
Physical Resistance/Sticking 54 54
Material Twisted/Bent 49 697
Separation Problem 48 48
Mechanical Jam 48 48
Device Remains Activated 42 42
Use of Device Problem 38 38
Mechanical Problem 37 37
Connection Problem 31 31
Smoking 31 31
Electrical /Electronic Property Problem 30 30
Fluid/Blood Leak 29 40
Dull, Blunt 24 24
Difficult to Remove 21 21
Naturally Worn 21 21
Loss of Power 20 20
Adverse Event Without Identified Device or Use Problem 19 19
Complete Loss of Power 19 19
Appropriate Term/Code Not Available 17 17
Material Deformation 16 21
Delivered as Unsterile Product 15 17
Material Disintegration 15 17
Defective Component 15 15
Device Alarm System 13 13
Material Integrity Problem 13 13
Self-Activation or Keying 12 12
Unintended Movement 12 12
Difficult to Insert 12 12
Device-Device Incompatibility 12 12
Entrapment of Device 11 11
Material Separation 11 11
Display or Visual Feedback Problem 9 9
Corroded 9 59
Insufficient Information 9 9
Intermittent Loss of Power 9 9
Fail-Safe Did Not Operate 9 9
Unintended System Motion 8 8
Fitting Problem 8 8
Tear, Rip or Hole in Device Packaging 8 10
Device Displays Incorrect Message 7 7
Power Problem 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4316 40712
No Consequences Or Impact To Patient 396 2724
No Patient Involvement 308 7384
No Known Impact Or Consequence To Patient 189 893
Insufficient Information 131 3441
Foreign Body In Patient 56 58
Device Embedded In Tissue or Plaque 52 52
Burn(s) 50 1496
Unintended Radiation Exposure 30 30
Superficial (First Degree) Burn 19 618
No Information 16 126
Hemorrhage/Bleeding 13 13
Injury 12 12
Unspecified Tissue Injury 11 11
Chemical Exposure 9 9
Spinal Cord Injury 9 9
Perforation 8 8
Pain 5 5
Numbness 4 4
Cerebrospinal Fluid Leakage 4 4
Nerve Damage 3 3
Paresis 3 3
Abrasion 3 3
Patient Problem/Medical Problem 2 2
Blood Loss 2 2
Unspecified Infection 2 2
Hematoma 2 2
Awareness during Anaesthesia 2 2
Hypoesthesia 2 2
Swelling/ Edema 2 2
Perforation of Vessels 2 2
Laceration(s) 2 2
Exposure to Body Fluids 1 1
Erythema 1 1
Bone Fracture(s) 1 1
Abscess 1 1
Intracranial Hemorrhage 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Visual Impairment 1 1
Tissue Damage 1 1
Pulmonary Dysfunction 1 1
Paralysis 1 1
Partial thickness (Second Degree) Burn 1 1
Full thickness (Third Degree) Burn 1 1
Radiation Exposure, Unintended 1 1
Necrosis 1 1
No Code Available 1 1
Cerebral Hyperperfusion Syndrome 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Xomed, Inc. II Oct-21-2021
2 Stryker Corporation II Jan-17-2025
3 Stryker Corporation II Jan-17-2025
4 Stryker Corporation II Oct-11-2024
5 Stryker Corporation II Aug-26-2024
6 Stryker Instruments II Jul-28-2022
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