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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

MDR Year MDR Reports MDR Events
2019 154 154
2020 142 142
2021 160 160
2022 143 143
2023 145 145
2024 114 114

Device Problems MDRs with this Device Problem Events in those MDRs
Calibration Problem 245 245
Break 190 190
Device-Device Incompatibility 113 113
Fracture 94 94
Naturally Worn 63 63
Mechanical Problem 54 54
Material Deformation 45 45
Material Twisted/Bent 33 33
Material Integrity Problem 28 28
Mechanical Jam 20 20
Detachment of Device or Device Component 16 16
Crack 15 15
Scratched Material 13 13
Physical Resistance/Sticking 11 11
Corroded 10 10
Unintended Movement 10 10
Component Missing 10 10
Failure to Cut 9 9
Failure to Calibrate 7 7
Use of Device Problem 5 5
Loose or Intermittent Connection 4 4
Appropriate Term/Code Not Available 4 4
Illegible Information 3 3
No Apparent Adverse Event 3 3
Structural Problem 3 3
Improper or Incorrect Procedure or Method 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 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
Difficult to Remove 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Packaging Problem 1 1
Defective Component 1 1
Inadequacy of Device Shape and/or Size 1 1
Tear, Rip or Hole in Device Packaging 1 1
Difficult to Advance 1 1
Activation Failure 1 1
Material Disintegration 1 1
Device Damaged Prior to Use 1 1
Accessory Incompatible 1 1
Device Contaminated During Manufacture or Shipping 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Component or Accessory Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 544 544
No Consequences Or Impact To Patient 149 149
No Patient Involvement 70 70
Insufficient Information 47 47
No Known Impact Or Consequence To Patient 33 33
No Code Available 15 15
No Information 7 7
Foreign Body In Patient 6 6
Not Applicable 5 5
Failure of Implant 2 2
Patient Problem/Medical Problem 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
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