Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
Device Remains Activated 32 32
Connection Problem 32 32
Fluid/Blood Leak 31 41
Smoking 26 26
Electrical /Electronic Property Problem 25 25
Dull, Blunt 19 19
Defective Component 17 17
Adverse Event Without Identified Device or Use Problem 17 17
Material Deformation 17 22
Complete Loss of Power 16 16
Material Disintegration 14 16
Difficult to Remove 13 13
Appropriate Term/Code Not Available 13 13
Material Integrity Problem 13 13
Material Separation 12 12
Device-Device Incompatibility 10 10
Entrapment of Device 10 10
Delivered as Unsterile Product 10 10
Insufficient Information 10 10
Unintended Movement 10 10
Intermittent Loss of Power 9 9
Display or Visual Feedback Problem 9 9
Self-Activation or Keying 9 9
Tear, Rip or Hole in Device Packaging 8 8
Computer Software Problem 7 7
Unintended System Motion 7 7
Loss of Power 7 7
Naturally Worn 7 7
Mechanics Altered 6 6
Power Problem 6 6
Premature Separation 6 6
Difficult to Insert 6 6
Expiration Date Error 6 6
Fitting Problem 6 6
Device Displays Incorrect Message 5 5
Misconnection 5 5
Intermittent Continuity 5 5
Fail-Safe Did Not Operate 5 5
Output Problem 4 4
Corroded 4 54
Leak/Splash 4 4
Image Display Error/Artifact 4 4
Failure to Power Up 4 4
Defective Device 4 4
Environmental Particulates 4 4
Communication or Transmission Problem 3 3
Loose or Intermittent Connection 3 3
Circuit Failure 3 3
Degraded 3 3
Temperature Problem 3 3
Packaging Problem 2 2
Scratched Material 2 2
Operating System Becomes Nonfunctional 2 2
Inadequate Lubrication 2 26
Difficult or Delayed Separation 2 2
Intermittent Communication Failure 2 2
Device Alarm System 2 2
Nonstandard Device 2 2
Peeled/Delaminated 2 2
Device Emits Odor 2 2
Blocked Connection 2 2
Fail-Safe Problem 2 2
Device Dislodged or Dislocated 2 2
Component Missing 2 2
Device Slipped 2 2
Improper or Incorrect Procedure or Method 2 2
Unstable 1 1
Failure to Calibrate 1 1
Failure to Align 1 1
Dent in Material 1 1
Electrical Shorting 1 1
Failure to Auto Stop 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Markings/Labelling Problem 1 1
Sparking 1 1
Difficult or Delayed Activation 1 1
Unsealed Device Packaging 1 1
Off-Label Use 1 1
Imprecision 1 1
Inability to Irrigate 1 1
Device Reprocessing Problem 1 1
Crack 1 1
Fire 1 1
Material Frayed 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
-
-