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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
2014 18 18
2015 34 34
2016 100 100
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 311 311
Calibration Problem 237 237
Device-Device Incompatibility 115 115
Fracture 111 111
Mechanical Problem 78 78
Naturally Worn 66 66
Appropriate Term/Code Not Available 50 50
Material Deformation 49 49
Material Twisted/Bent 38 38
Mechanical Jam 34 34
Crack 28 28
Material Integrity Problem 27 27
Device Operates Differently Than Expected 25 25
Component Missing 24 24
Detachment of Device or Device Component 15 15
Bent 14 14
Scratched Material 14 14
Physical Resistance/Sticking 11 11
Unintended Movement 11 11
Corroded 10 10
Disassembly 10 10
Loose or Intermittent Connection 9 9
Failure to Cut 9 9
Output above Specifications 8 8
Failure to Calibrate 7 7
Output Problem 7 7
Material Torqued 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Difficult to Remove 5 5
Use of Device Problem 5 5
Device Inoperable 4 4
Material Fragmentation 3 3
Structural Problem 3 3
Connection Problem 3 3
Entrapment of Device 3 3
Component or Accessory Incompatibility 3 3
Sticking 3 3
Illegible Information 3 3
Detachment Of Device Component 2 2
Output below Specifications 2 2
Separation Failure 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Failure to Disconnect 2 2
Improper or Incorrect Procedure or Method 2 2
Device Issue 2 2
Failure To Adhere Or Bond 2 2
Fitting Problem 2 2
Compatibility Problem 2 2
Insufficient Information 2 2
Unstable 2 2

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 240 240
No Known Impact Or Consequence To Patient 180 180
No Patient Involvement 107 107
No Information 78 78
Insufficient Information 41 41
No Code Available 28 28
Not Applicable 14 14
Foreign Body In Patient 8 8
Injury 7 7
Sedation 7 7
Device Embedded In Tissue or Plaque 4 4
Failure of Implant 3 3
Bone Fracture(s) 2 2
Spinal Column Injury 2 2
Patient Problem/Medical Problem 1 1
Complaint, Ill-Defined 1 1
Tissue Damage 1 1
Vertebral Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap, Inc. II Aug-03-2015
2 Biomet Spine, LLC II Apr-20-2015
3 Bradshaw Medical Inc. II May-10-2016
4 DePuy Spine, Inc. II Jan-16-2013
5 New Standard Device Inc II Jun-21-2022
6 Orthofix, Inc II Feb-11-2016
7 Zimmer Inc. II Mar-04-2009
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