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TPLC
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show TPLC since
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Device
wrench
Product Code
HXC
Regulation Number
888.4540
Device Class
1
Premarket Reviews
Manufacturer
Decision
GAUTHIER BIOMEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
111
111
2019
154
154
2020
142
142
2021
160
160
2022
143
143
2023
126
126
Device Problems
MDRs with this Device Problem
Events in those MDRs
Calibration Problem
197
197
Break
176
176
Device-Device Incompatibility
97
97
Fracture
94
94
Mechanical Problem
64
64
Naturally Worn
60
60
Material Deformation
43
43
Material Twisted/Bent
31
31
Mechanical Jam
31
31
Material Integrity Problem
27
27
Crack
17
17
Appropriate Term/Code Not Available
16
16
Scratched Material
13
13
Component Missing
12
12
Physical Resistance/Sticking
11
11
Detachment of Device or Device Component
10
10
Corroded
10
10
Failure to Cut
9
9
Unintended Movement
9
9
Failure to Calibrate
7
7
Device Operates Differently Than Expected
5
5
Bent
5
5
Loose or Intermittent Connection
5
5
Use of Device Problem
5
5
Difficult to Remove
4
4
Disassembly
4
4
Structural Problem
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Illegible Information
3
3
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Compatibility Problem
2
2
Separation Failure
2
2
Device Issue
2
2
Unstable
2
2
Connection Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Device Damaged Prior to Use
1
1
Defective Component
1
1
Inadequacy of Device Shape and/or Size
1
1
Material Disintegration
1
1
Entrapment of Device
1
1
Degraded
1
1
Accessory Incompatible
1
1
Activation, Positioning or Separation Problem
1
1
Contamination /Decontamination Problem
1
1
Component or Accessory Incompatibility
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Tear, Rip or Hole in Device Packaging
1
1
Dull, Blunt
1
1
Defective Device
1
1
Device Contaminated During Manufacture or Shipping
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Difficult to Advance
1
1
Device Contamination with Chemical or Other Material
1
1
Packaging Problem
1
1
Difficult or Delayed Separation
1
1
Activation Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
438
438
No Consequences Or Impact To Patient
223
223
No Patient Involvement
80
80
No Known Impact Or Consequence To Patient
47
47
Insufficient Information
19
19
No Code Available
18
18
Not Applicable
12
12
No Information
10
10
Foreign Body In Patient
6
6
Device Embedded In Tissue or Plaque
4
4
Failure of Implant
2
2
Vertebral Fracture
1
1
Patient Problem/Medical Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
New Standard Device Inc
II
Jun-21-2022
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