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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
STRYKER INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
SURGIFY MEDICAL OY
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2020 1025 10801
2021 1047 10601
2022 900 7868
2023 948 7089
2024 1153 7145
2025 1218 3718

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 2510 17461
Fracture 1602 1838
Flaked 636 25574
Vibration 335 335
Break 256 262
Detachment of Device or Device Component 231 418
Excessive Heating 219 219
Material Fragmentation 171 171
Noise, Audible 132 132
No Apparent Adverse Event 110 110
Physical Resistance/Sticking 57 57
Device Remains Activated 54 54
Mechanical Jam 52 52
Material Twisted/Bent 50 698
Separation Problem 49 49
Electrical /Electronic Property Problem 41 41
Use of Device Problem 40 40
Mechanical Problem 40 40
Fluid/Blood Leak 39 50
Device Alarm System 35 35
Loss of Power 34 34
Smoking 34 34
Connection Problem 34 34
Naturally Worn 32 32
Complete Loss of Power 30 30
Difficult to Remove 28 28
Dull, Blunt 27 27
Appropriate Term/Code Not Available 26 26
Adverse Event Without Identified Device or Use Problem 22 22
Difficult to Insert 20 20
Material Deformation 17 22
Delivered as Unsterile Product 16 18
Material Disintegration 16 18
Defective Component 15 15
Self-Activation or Keying 14 14
Device Displays Incorrect Message 14 14
Device-Device Incompatibility 14 14
Unintended Movement 13 13
Material Integrity Problem 13 13
Fail-Safe Did Not Operate 12 12
Unintended System Motion 11 11
Entrapment of Device 11 11
Material Separation 11 11
Corroded 10 60
Intermittent Loss of Power 10 10
Insufficient Information 9 9
Display or Visual Feedback Problem 9 9
Material Frayed 9 9
Premature Separation 8 8
Fitting Problem 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5319 42967
No Consequences Or Impact To Patient 396 2724
No Patient Involvement 308 7384
No Known Impact Or Consequence To Patient 189 893
Insufficient Information 178 3684
Foreign Body In Patient 59 61
Device Embedded In Tissue or Plaque 57 57
Burn(s) 56 1550
Unintended Radiation Exposure 31 31
Superficial (First Degree) Burn 20 761
No Information 16 126
Hemorrhage/Bleeding 13 13
Injury 12 12
Unspecified Tissue Injury 11 11
Spinal Cord Injury 9 9
Chemical Exposure 9 9
Perforation 8 8
Cerebrospinal Fluid Leakage 5 5
Pain 5 5
Numbness 4 4
Nicks, cuts or tears of dura or other tissues by device 3 3
Hematoma 3 3
Abrasion 3 3
Paresis 3 3
Nerve Damage 3 3
Hypoesthesia 2 2
Partial thickness (Second Degree) Burn 2 38
Perforation of Vessels 2 2
Swelling/ Edema 2 2
Awareness during Anaesthesia 2 2
Laceration(s) 2 2
Blood Loss 2 2
Unspecified Infection 2 2
Patient Problem/Medical Problem 2 2
Alteration in Body Temperature 1 1
Exposure to Body Fluids 1 1
Erythema 1 1
Paralysis 1 1
Visual Impairment 1 1
Intracranial Hemorrhage 1 1
Abscess 1 1
Epistaxis 1 1
Cerebral Hyperperfusion Syndrome 1 1
Tissue Damage 1 1
Bone Fracture(s) 1 1
Necrosis 1 1
No Code Available 1 1
Radiation Exposure, Unintended 1 1
Pulmonary Dysfunction 1 1
Urinary Frequency 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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