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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 160 160
2022 143 143
2023 145 145
2024 81 81

Device Problems MDRs with this Device Problem Events in those MDRs
Break 244 244
Calibration Problem 234 234
Device-Device Incompatibility 114 114
Fracture 102 102
Mechanical Problem 74 74
Naturally Worn 66 66
Material Deformation 47 47
Material Twisted/Bent 38 38
Appropriate Term/Code Not Available 37 37
Mechanical Jam 34 34
Material Integrity Problem 27 27
Crack 23 23
Device Operates Differently Than Expected 23 23
Detachment of Device or Device Component 15 15
Component Missing 15 15
Scratched Material 14 14
Physical Resistance/Sticking 11 11
Unintended Movement 11 11
Corroded 10 10
Bent 10 10
Failure to Cut 9 9
Disassembly 8 8
Failure to Calibrate 7 7
Loose or Intermittent Connection 6 6
Difficult to Remove 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Use of Device Problem 5 5
Output above Specifications 4 4
Illegible Information 3 3
Structural Problem 3 3
Device Issue 2 2
Improper or Incorrect Procedure or Method 2 2
Connection Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Insufficient Information 2 2
Separation Failure 2 2
Compatibility Problem 2 2
Unstable 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Degraded 1 1
Contamination /Decontamination Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Device 1 1
Misconnection 1 1
Packaging Problem 1 1
Difficult or Delayed Separation 1 1
Defective Component 1 1
Inadequacy of Device Shape and/or Size 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 517 517
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
Insufficient Information 41 41
No Code Available 20 20
Not Applicable 14 14
Foreign Body In Patient 7 7
Device Embedded In Tissue or Plaque 4 4
Failure of Implant 2 2
Spinal Column Injury 2 2
Patient Problem/Medical Problem 1 1
Bone Fracture(s) 1 1
Injury 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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