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 bender
Product CodeHXW
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2017 22 22
2018 43 43
2019 24 24
2020 16 16
2021 11 11
2022 10 10
2023 12 12
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 42 42
Fracture 30 30
Disassembly 14 14
Material Deformation 14 14
Device Inoperable 7 7
Detachment of Device or Device Component 7 7
Material Twisted/Bent 4 4
Mechanical Jam 4 4
Sticking 3 3
Physical Resistance/Sticking 3 3
Device Operates Differently Than Expected 3 3
Mechanical Problem 3 3
Device Slipped 2 2
Corroded 2 2
Degraded 2 2
Device Operational Issue 2 2
Device-Device Incompatibility 2 2
Mechanics Altered 2 2
Naturally Worn 1 1
No Apparent Adverse Event 1 1
Separation Failure 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Loose or Intermittent Connection 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 61 61
No Clinical Signs, Symptoms or Conditions 31 31
No Consequences Or Impact To Patient 30 30
No Patient Involvement 7 7
No Information 5 5
No Code Available 4 4
Insufficient Information 1 1
Foreign Body In Patient 1 1
Nerve Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Jul-19-2022
-
-