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 instrument, compression
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWN
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2021 88 88
2022 64 64
2023 82 82
2024 83 83
2025 181 181

Device Problems MDRs with this Device Problem Events in those MDRs
Break 250 250
Device-Device Incompatibility 75 75
Naturally Worn 39 39
Material Deformation 35 35
Crack 33 33
Material Twisted/Bent 28 28
Entrapment of Device 15 15
Failure to Cut 15 15
Detachment of Device or Device Component 11 11
Mechanical Jam 11 11
Structural Problem 10 10
Residue After Decontamination 10 10
Fracture 10 10
Scratched Material 5 5
Contamination /Decontamination Problem 4 4
Material Too Rigid or Stiff 4 4
Difficult to Open or Close 4 4
Mechanical Problem 3 3
Unintended Movement 3 3
Difficult to Insert 3 3
Material Discolored 3 3
Corroded 3 3
Device Slipped 2 2
Physical Resistance/Sticking 2 2
Material Integrity Problem 2 2
Failure to Align 2 2
No Apparent Adverse Event 2 2
Material Frayed 1 1
Off-Label Use 1 1
Insufficient Information 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Fragmentation 1 1
Positioning Failure 1 1
Use of Device Problem 1 1
Device Dislodged or Dislocated 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 427 427
Insufficient Information 59 59
Foreign Body In Patient 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Foreign Body Reaction 1 1
No Consequences Or Impact To Patient 1 1

-
-