• 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 wrench
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXC
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 142 142
2021 160 160
2022 143 143
2023 145 145
2024 126 126
2025 54 54

Device Problems MDRs with this Device Problem Events in those MDRs
Calibration Problem 219 219
Break 176 176
Device-Device Incompatibility 114 114
Fracture 95 95
Naturally Worn 58 58
Material Deformation 50 50
Material Integrity Problem 28 28
Material Twisted/Bent 24 24
Mechanical Problem 23 23
Detachment of Device or Device Component 18 18
Mechanical Jam 15 15
Corroded 14 14
Crack 13 13
Scratched Material 12 12
Unintended Movement 10 10
Failure to Cut 9 9
No Apparent Adverse Event 4 4
Component Missing 4 4
Use of Device Problem 4 4
Contamination /Decontamination Problem 4 4
Compatibility Problem 4 4
Degraded 3 3
Structural Problem 3 3
Illegible Information 3 3
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Separation Failure 2 2
Physical Resistance/Sticking 2 2
Failure to Calibrate 2 2
Appropriate Term/Code Not Available 2 2
Improper or Incorrect Procedure or Method 2 2
Unstable 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Advance 1 1
Packaging Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Accessory Incompatible 1 1
Activation Failure 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 600 600
No Consequences Or Impact To Patient 66 66
Insufficient Information 57 57
No Patient Involvement 31 31
No Known Impact Or Consequence To Patient 13 13
No Code Available 10 10
Foreign Body In Patient 5 5
No Information 4 4
Failure of Implant 2 2
Patient Problem/Medical Problem 1 1
Not Applicable 1 1
Vertebral Fracture 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 New Standard Device Inc II Jun-21-2022
-
-