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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
114
114
Device Problems
MDRs with this Device Problem
Events in those MDRs
Calibration Problem
245
245
Break
190
190
Device-Device Incompatibility
113
113
Fracture
94
94
Naturally Worn
63
63
Mechanical Problem
54
54
Material Deformation
45
45
Material Twisted/Bent
33
33
Material Integrity Problem
28
28
Mechanical Jam
20
20
Detachment of Device or Device Component
16
16
Crack
15
15
Scratched Material
13
13
Physical Resistance/Sticking
11
11
Corroded
10
10
Unintended Movement
10
10
Component Missing
10
10
Failure to Cut
9
9
Failure to Calibrate
7
7
Use of Device Problem
5
5
Loose or Intermittent Connection
4
4
Appropriate Term/Code Not Available
4
4
Illegible Information
3
3
No Apparent Adverse Event
3
3
Structural Problem
3
3
Improper or Incorrect Procedure or Method
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Separation Failure
2
2
Compatibility Problem
2
2
Unstable
2
2
Device Misassembled During Manufacturing /Shipping
1
1
Degraded
1
1
Contamination /Decontamination Problem
1
1
Difficult to Remove
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Packaging Problem
1
1
Defective Component
1
1
Inadequacy of Device Shape and/or Size
1
1
Tear, Rip or Hole in Device Packaging
1
1
Difficult to Advance
1
1
Activation Failure
1
1
Material Disintegration
1
1
Device Damaged Prior to Use
1
1
Accessory Incompatible
1
1
Device Contaminated During Manufacture or Shipping
1
1
Connection Problem
1
1
Activation, Positioning or Separation 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
544
544
No Consequences Or Impact To Patient
149
149
No Patient Involvement
70
70
Insufficient Information
47
47
No Known Impact Or Consequence To Patient
33
33
No Code Available
15
15
No Information
7
7
Foreign Body In Patient
6
6
Not Applicable
5
5
Failure of Implant
2
2
Patient Problem/Medical Problem
1
1
Vertebral Fracture
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
New Standard Device Inc
II
Jun-21-2022
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