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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
2017 118 118
2018 111 111
2019 154 154
2020 142 142
2021 161 161
2022 115 115

Device Problems MDRs with this Device Problem Events in those MDRs
Break 174 174
Calibration Problem 170 170
Fracture 78 78
Mechanical Problem 73 73
Device-Device Incompatibility 69 69
Appropriate Term/Code Not Available 37 37
Naturally Worn 31 31
Material Twisted/Bent 30 30
Mechanical Jam 30 30
Material Deformation 26 26
Material Integrity Problem 24 24
Device Operates Differently Than Expected 23 23
Crack 20 20
Component Missing 15 15
Physical Resistance/Sticking 11 11
Corroded 10 10
Bent 10 10
Disassembly 8 8
Unintended Movement 8 8
Failure to Calibrate 7 7
Loose or Intermittent Connection 6 6
Difficult to Remove 5 5
Use of Device Problem 5 5
Detachment of Device or Device Component 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Output above Specifications 4 4
Scratched Material 3 3
Insufficient Information 2 2
Compatibility Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Unstable 2 2
Separation Failure 2 2
Failure to Cut 2 2
Device Issue 2 2
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Structural Problem 1 1
Defective Device 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Contamination /Decontamination Problem 1 1
Component or Accessory Incompatibility 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Misconnection 1 1
Material Disintegration 1 1
Entrapment of Device 1 1
Degraded 1 1
Accessory Incompatible 1 1
Difficult or Delayed Separation 1 1
Activation Failure 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
Output below Specifications 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 292 292
No Consequences Or Impact To Patient 236 236
No Patient Involvement 93 93
No Known Impact Or Consequence To Patient 88 88
No Information 54 54
No Code Available 20 20
Not Applicable 14 14
Insufficient Information 12 12
Foreign Body In Patient 7 7
Device Embedded In Tissue or Plaque 4 4
Failure of Implant 2 2
Spinal Column Injury 2 2
Injury 1 1
Patient Problem/Medical Problem 1 1
Bone Fracture(s) 1 1
Vertebral Fracture 1 1

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