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TPLC
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show TPLC since
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2019
2020
2021
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2024
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Device
wrench
Product Code
HXC
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
154
154
2020
142
142
2021
160
160
2022
143
143
2023
145
145
2024
19
19
Device Problems
MDRs with this Device Problem
Events in those MDRs
Calibration Problem
211
211
Break
169
169
Device-Device Incompatibility
97
97
Fracture
87
87
Naturally Worn
58
58
Mechanical Problem
53
53
Material Deformation
41
41
Material Integrity Problem
27
27
Material Twisted/Bent
26
26
Mechanical Jam
19
19
Crack
14
14
Detachment of Device or Device Component
13
13
Scratched Material
12
12
Physical Resistance/Sticking
11
11
Corroded
10
10
Component Missing
10
10
Unintended Movement
9
9
Failure to Cut
9
9
Failure to Calibrate
7
7
Use of Device Problem
5
5
Loose or Intermittent Connection
4
4
Structural Problem
3
3
Appropriate Term/Code Not Available
3
3
Illegible Information
3
3
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Separation Failure
2
2
Compatibility Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Unstable
2
2
Accessory Incompatible
1
1
Tear, Rip or Hole in Device Packaging
1
1
Device Damaged Prior to Use
1
1
Defective Component
1
1
Difficult to Remove
1
1
Inadequacy of Device Shape and/or Size
1
1
Degraded
1
1
Material Disintegration
1
1
Device Contaminated During Manufacture or Shipping
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Difficult to Advance
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Contamination /Decontamination Problem
1
1
Component or Accessory Incompatibility
1
1
Connection Problem
1
1
Activation, Positioning or Separation Problem
1
1
Packaging Problem
1
1
No Apparent Adverse Event
1
1
Activation Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
468
468
No Consequences Or Impact To Patient
149
149
No Patient Involvement
70
70
No Known Impact Or Consequence To Patient
33
33
Insufficient Information
27
27
No Code Available
15
15
No Information
7
7
Foreign Body In Patient
6
6
Not Applicable
5
5
Failure of Implant
2
2
Device Embedded In Tissue or Plaque
1
1
Patient Problem/Medical Problem
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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