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TPLC
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show TPLC since
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2024
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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
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
244
244
Calibration Problem
234
234
Device-Device Incompatibility
114
114
Fracture
102
102
Mechanical Problem
74
74
Naturally Worn
66
66
Material Deformation
47
47
Material Twisted/Bent
38
38
Appropriate Term/Code Not Available
37
37
Mechanical Jam
34
34
Material Integrity Problem
27
27
Crack
23
23
Device Operates Differently Than Expected
23
23
Detachment of Device or Device Component
15
15
Component Missing
15
15
Scratched Material
14
14
Physical Resistance/Sticking
11
11
Unintended Movement
11
11
Bent
10
10
Corroded
10
10
Failure to Cut
9
9
Disassembly
8
8
Failure to Calibrate
7
7
Loose or Intermittent Connection
6
6
Adverse Event Without Identified Device or Use Problem
5
5
Difficult to Remove
5
5
Use of Device Problem
5
5
Output above Specifications
4
4
Structural Problem
3
3
Illegible Information
3
3
Connection Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Device Issue
2
2
Separation Failure
2
2
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Insufficient Information
2
2
Unstable
2
2
Compatibility Problem
2
2
Degraded
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Defective Component
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Defective Device
1
1
Material Disintegration
1
1
Contamination /Decontamination Problem
1
1
Difficult to Advance
1
1
Device Damaged Prior to Use
1
1
Misconnection
1
1
Difficult or Delayed Separation
1
1
Packaging Problem
1
1
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
236
236
No Patient Involvement
93
93
No Known Impact Or Consequence To Patient
88
88
No Information
54
54
Insufficient Information
41
41
No Code Available
20
20
Not Applicable
14
14
Foreign Body In Patient
7
7
Device Embedded In Tissue or Plaque
4
4
Failure of Implant
2
2
Spinal Column Injury
2
2
Patient Problem/Medical Problem
1
1
Bone Fracture(s)
1
1
Injury
1
1
Vertebral Fracture
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
New Standard Device Inc
II
Jun-21-2022
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