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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 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Break 294 294
Calibration Problem 217 217
Fracture 110 110
Device-Device Incompatibility 103 103
Mechanical Problem 78 78
Naturally Worn 65 65
Appropriate Term/Code Not Available 50 50
Material Deformation 46 46
Mechanical Jam 34 34
Material Twisted/Bent 31 31
Material Integrity Problem 27 27
Crack 27 27
Device Operates Differently Than Expected 25 25
Component Missing 24 24
Bent 14 14
Detachment of Device or Device Component 13 13
Scratched Material 13 13
Physical Resistance/Sticking 11 11
Unintended Movement 10 10
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
Structural Problem 3 3
Entrapment of Device 3 3
Material Fragmentation 3 3
Sticking 3 3
Component or Accessory Incompatibility 3 3
Connection Problem 3 3
Illegible Information 3 3
Insufficient Information 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Compatibility Problem 2 2
Output below Specifications 2 2
Detachment Of Device Component 2 2
Failure To Adhere Or Bond 2 2
Failure to Disconnect 2 2
Separation Failure 2 2
Device Issue 2 2
Unstable 2 2
Improper or Incorrect Procedure or Method 2 2
Fitting Problem 2 2
Device Damaged Prior to Use 1 1
Defective Component 1 1
Inadequacy of Device Shape and/or Size 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Failure to Advance 1 1
Accessory Incompatible 1 1
Degraded 1 1
Material Discolored 1 1
Material Disintegration 1 1
Misconnection 1 1
Mechanics Altered 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Activation Failure 1 1
Noise, Audible 1 1
Misassembly by Users 1 1
No Apparent Adverse Event 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Operational Issue 1 1
Difficult to Advance 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Activation, Positioning or Separation Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Difficult or Delayed Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 473 473
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
No Code Available 28 28
Insufficient Information 27 27
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
Spinal Column Injury 2 2
Bone Fracture(s) 2 2
Vertebral Fracture 1 1
Tissue Damage 1 1
Complaint, Ill-Defined 1 1
Patient Problem/Medical Problem 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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