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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Product CodeHXC
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
GAUTHIER BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 111 111
2019 154 154
2020 142 142
2021 160 160
2022 143 143
2023 126 126

Device Problems MDRs with this Device Problem Events in those MDRs
Calibration Problem 197 197
Break 176 176
Device-Device Incompatibility 97 97
Fracture 94 94
Mechanical Problem 64 64
Naturally Worn 60 60
Material Deformation 43 43
Material Twisted/Bent 31 31
Mechanical Jam 31 31
Material Integrity Problem 27 27
Crack 17 17
Appropriate Term/Code Not Available 16 16
Scratched Material 13 13
Component Missing 12 12
Physical Resistance/Sticking 11 11
Detachment of Device or Device Component 10 10
Corroded 10 10
Failure to Cut 9 9
Unintended Movement 9 9
Failure to Calibrate 7 7
Device Operates Differently Than Expected 5 5
Bent 5 5
Loose or Intermittent Connection 5 5
Use of Device Problem 5 5
Difficult to Remove 4 4
Disassembly 4 4
Structural Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Illegible Information 3 3
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Compatibility Problem 2 2
Separation Failure 2 2
Device Issue 2 2
Unstable 2 2
Connection Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Device Damaged Prior to Use 1 1
Defective Component 1 1
Inadequacy of Device Shape and/or Size 1 1
Material Disintegration 1 1
Entrapment of Device 1 1
Degraded 1 1
Accessory Incompatible 1 1
Activation, Positioning or Separation Problem 1 1
Contamination /Decontamination Problem 1 1
Component or Accessory Incompatibility 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Defective Device 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Advance 1 1
Device Contamination with Chemical or Other Material 1 1
Packaging Problem 1 1
Difficult or Delayed Separation 1 1
Activation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 438 438
No Consequences Or Impact To Patient 223 223
No Patient Involvement 80 80
No Known Impact Or Consequence To Patient 47 47
Insufficient Information 19 19
No Code Available 18 18
Not Applicable 12 12
No Information 10 10
Foreign Body In Patient 6 6
Device Embedded In Tissue or Plaque 4 4
Failure of Implant 2 2
Vertebral Fracture 1 1
Patient Problem/Medical Problem 1 1

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