• 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 driver, prosthesis
Product CodeHWR
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 738 738
2021 898 898
2022 980 980
2023 1281 1281
2024 1212 1212

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2392 2392
Material Twisted/Bent 1474 1474
Device-Device Incompatibility 674 674
Naturally Worn 355 355
Material Deformation 211 211
Crack 191 191
Entrapment of Device 93 93
Fracture 73 73
Mechanical Problem 73 73
Material Integrity Problem 73 73
Mechanical Jam 69 69
Contamination /Decontamination Problem 40 40
Failure to Cut 26 26
Unintended Movement 26 26
No Apparent Adverse Event 22 22
Detachment of Device or Device Component 21 21
Adverse Event Without Identified Device or Use Problem 19 19
Appropriate Term/Code Not Available 16 16
Scratched Material 12 12
Device Slipped 12 12
Component Missing 11 11
Structural Problem 11 11
Corroded 9 9
Physical Resistance/Sticking 7 7
Calibration Problem 7 7
Use of Device Problem 5 5
Material Split, Cut or Torn 4 4
Illegible Information 3 3
Loose or Intermittent Connection 3 3
Improper or Incorrect Procedure or Method 3 3
Defective Device 2 2
Defective Component 2 2
Material Fragmentation 2 2
Material Discolored 2 2
Flaked 2 2
Device Fell 1 1
Difficult to Remove 1 1
Difficult to Insert 1 1
Moisture or Humidity Problem 1 1
Off-Label Use 1 1
Material Separation 1 1
Device Reprocessing Problem 1 1
Connection Problem 1 1
Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4080 4080
No Consequences Or Impact To Patient 554 554
Insufficient Information 416 416
No Code Available 86 86
Foreign Body In Patient 59 59
No Patient Involvement 31 31
Not Applicable 6 6
No Information 6 6
No Known Impact Or Consequence To Patient 4 4
Injury 4 4
Limb Fracture 4 4
Pain 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Neuropathy 1 1
Unspecified Infection 1 1
Failure of Implant 1 1
Bone Fracture(s) 1 1
Foreign Body Reaction 1 1
Burn(s) 1 1
Nerve Damage 1 1
Device Embedded In Tissue or Plaque 1 1

-
-