Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device wrench
Product CodeHXC
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
GAUTHIER BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 265 265
Calibration Problem 217 217
Fracture 108 108
Device-Device Incompatibility 103 103
Mechanical Problem 78 78
Naturally Worn 65 65
Appropriate Term/Code Not Available 50 50
Material Deformation 44 44
Mechanical Jam 34 34
Material Twisted/Bent 31 31
Material Integrity Problem 27 27
Crack 26 26
Device Operates Differently Than Expected 25 25
Component Missing 23 23
Bent 14 14
Detachment of Device or Device Component 13 13
Scratched Material 13 13
Physical Resistance/Sticking 11 11
Unintended Movement 10 10
Disassembly 10 10
Corroded 10 10
Failure to Cut 9 9
Loose or Intermittent Connection 8 8
Failure to Calibrate 7 7
Output Problem 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Use of Device Problem 5 5
Output above Specifications 5 5
Difficult to Remove 5 5
Device Inoperable 4 4
Structural Problem 3 3
Entrapment of Device 3 3
Illegible Information 3 3
Connection Problem 3 3
Compatibility Problem 2 2
Insufficient Information 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Material Fragmentation 2 2
Failure to Disconnect 2 2
Separation Failure 2 2
Device Issue 2 2
Unstable 2 2
Sticking 2 2
Improper or Incorrect Procedure or Method 2 2
Device Damaged Prior to Use 1 1
Defective Component 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Failure to Advance 1 1
Inadequacy of Device Shape and/or Size 1 1
Misconnection 1 1
Material Discolored 1 1
Material Disintegration 1 1
Degraded 1 1
Accessory Incompatible 1 1
Detachment Of Device Component 1 1
Activation Failure 1 1
Difficult or Delayed Separation 1 1
Output below Specifications 1 1
Packaging Problem 1 1
No Apparent Adverse Event 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Torqued 1 1
Device Operational Issue 1 1
Difficult to Advance 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
Component or Accessory Incompatibility 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 237 237
No Known Impact Or Consequence To Patient 147 147
No Patient Involvement 105 105
No Information 76 76
Insufficient Information 27 27
No Code Available 22 22
Not Applicable 14 14
Foreign Body In Patient 8 8
Device Embedded In Tissue or Plaque 4 4
Injury 3 3
Failure of Implant 3 3
Spinal Column Injury 2 2
Sedation 2 2
Patient Problem/Medical Problem 1 1
Bone Fracture(s) 1 1
Vertebral Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bradshaw Medical Inc. II May-10-2016
2 New Standard Device Inc II Jun-21-2022
3 Orthofix, Inc II Feb-11-2016
-
-