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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 2
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
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SURGIFY MEDICAL OY
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 836 8856
2020 1025 10801
2021 1047 10601
2022 900 7868
2023 948 7089
2024 259 1643

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 1878 13045
Fracture 1203 1388
Flaked 643 30243
Break 328 376
Vibration 264 264
Detachment of Device or Device Component 182 267
Excessive Heating 173 173
Material Fragmentation 142 143
Noise, Audible 86 86
No Apparent Adverse Event 80 80
Material Twisted/Bent 68 883
Physical Resistance/Sticking 50 50
Mechanical Jam 47 47
Separation Problem 43 43
Mechanical Problem 35 35
Use of Device Problem 35 35
Connection Problem 32 32
Device Remains Activated 32 32
Fluid/Blood Leak 31 41
Smoking 26 26
Electrical /Electronic Property Problem 25 25
Dull, Blunt 19 19
Material Deformation 17 22
Adverse Event Without Identified Device or Use Problem 17 17
Defective Component 17 17
Complete Loss of Power 16 16
Material Disintegration 14 16
Difficult to Remove 13 13
Material Integrity Problem 13 13
Appropriate Term/Code Not Available 13 13
Material Separation 12 12
Device-Device Incompatibility 10 10
Unintended Movement 10 10
Entrapment of Device 10 10
Insufficient Information 10 10
Delivered as Unsterile Product 10 10
Self-Activation or Keying 9 9
Display or Visual Feedback Problem 9 9
Intermittent Loss of Power 9 9
Tear, Rip or Hole in Device Packaging 8 8
Unintended System Motion 7 7
Loss of Power 7 7
Naturally Worn 7 7
Computer Software Problem 7 7
Premature Separation 6 6
Mechanics Altered 6 6
Difficult to Insert 6 6
Fitting Problem 6 6
Power Problem 6 6
Expiration Date Error 6 6
Fail-Safe Did Not Operate 5 5
Misconnection 5 5
Device Displays Incorrect Message 5 5
Intermittent Continuity 5 5
Corroded 4 54
Leak/Splash 4 4
Image Display Error/Artifact 4 4
Environmental Particulates 4 4
Failure to Power Up 4 4
Defective Device 4 4
Output Problem 4 4
Temperature Problem 3 3
Loose or Intermittent Connection 3 3
Communication or Transmission Problem 3 3
Circuit Failure 3 3
Degraded 3 3
Difficult or Delayed Separation 2 2
Component Missing 2 2
Device Dislodged or Dislocated 2 2
Inadequate Lubrication 2 26
Fail-Safe Problem 2 2
Intermittent Communication Failure 2 2
Operating System Becomes Nonfunctional 2 2
Improper or Incorrect Procedure or Method 2 2
Device Alarm System 2 2
Scratched Material 2 2
Blocked Connection 2 2
Device Slipped 2 2
Packaging Problem 2 2
Nonstandard Device 2 2
Device Emits Odor 2 2
Peeled/Delaminated 2 2
Dent in Material 1 1
Inappropriate Tactile Prompt/Feedback 1 1
Electrical Shorting 1 1
Off-Label Use 1 1
Material Protrusion/Extrusion 1 1
Unsealed Device Packaging 1 1
Inaccurate Information 1 1
Failure to Align 1 1
Difficult to Open or Remove Packaging Material 1 1
Crack 1 1
Inability to Irrigate 1 1
Difficult or Delayed Activation 1 1
Imprecision 1 1
Device Markings/Labelling Problem 1 1
Unstable 1 1
Sparking 1 1
Device Reprocessing Problem 1 1
Interrogation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3302 34157
No Consequences Or Impact To Patient 773 6632
No Patient Involvement 623 14239
No Known Impact Or Consequence To Patient 366 1979
Insufficient Information 86 1952
Foreign Body In Patient 58 59
Device Embedded In Tissue or Plaque 54 54
Burn(s) 42 641
Unintended Radiation Exposure 28 28
No Information 23 133
Superficial (First Degree) Burn 23 356
Injury 18 18
Perforation 15 15
Hemorrhage/Bleeding 11 11
Chemical Exposure 10 10
Spinal Cord Injury 9 9
Unspecified Tissue Injury 9 9
Radiation Exposure, Unintended 8 8
Abrasion 5 5
Pain 5 5
Numbness 4 4
Paresis 3 3
Nerve Damage 3 3
Perforation of Vessels 2 2
Unspecified Infection 2 2
Laceration(s) 2 2
Cerebrospinal Fluid Leakage 2 2
Hematoma 2 2
Burn, Thermal 2 41
Blood Loss 2 2
Patient Problem/Medical Problem 2 2
Partial thickness (Second Degree) Burn 2 7
Swelling/ Edema 2 2
No Code Available 1 1
Cerebral Hyperperfusion Syndrome 1 1
Hypoesthesia 1 1
Brain Injury 1 1
Death 1 1
Erythema 1 1
Bone Fracture(s) 1 1
Abscess 1 1
Awareness during Anaesthesia 1 1
Visual Impairment 1 1
Pulmonary Dysfunction 1 1
Tissue Damage 1 1
Oversedation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Xomed, Inc. II Oct-21-2021
2 Stryker Instruments II Jul-28-2022
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