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 osteotome
Regulation Description Manual surgical instrument for general use.
Product CodeHWM
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 57 57
2021 73 73
2022 75 75
2023 72 72
2024 93 93
2025 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Break 194 194
Failure to Cut 87 87
Material Deformation 57 57
Fracture 24 24
Device-Device Incompatibility 21 21
Material Integrity Problem 20 20
Material Twisted/Bent 17 17
Scratched Material 15 15
Naturally Worn 15 15
Contamination /Decontamination Problem 11 11
Device Slipped 5 5
Crack 5 5
Use of Device Problem 4 4
Dull, Blunt 4 4
Unintended Movement 3 3
Detachment of Device or Device Component 3 3
Illegible Information 3 3
Corroded 3 3
Mechanical Jam 3 3
Mechanical Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Apparent Adverse Event 2 2
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Peeled/Delaminated 1 1
Insufficient Information 1 1
Defective Component 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Structural Problem 1 1
Material Separation 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 299 299
Insufficient Information 39 39
No Consequences Or Impact To Patient 38 38
Foreign Body In Patient 5 5
No Patient Involvement 4 4
Bone Fracture(s) 2 2
No Known Impact Or Consequence To Patient 2 2
No Code Available 1 1
Perforation 1 1
Limb Fracture 1 1

-
-