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TPLC
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Device
wrench
Regulation Description
Orthopedic manual surgical instrument.
Product Code
HXC
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
142
142
2021
160
160
2022
143
143
2023
145
145
2024
126
126
2025
54
54
Device Problems
MDRs with this Device Problem
Events in those MDRs
Calibration Problem
219
219
Break
176
176
Device-Device Incompatibility
114
114
Fracture
95
95
Naturally Worn
58
58
Material Deformation
50
50
Material Integrity Problem
28
28
Material Twisted/Bent
24
24
Mechanical Problem
23
23
Detachment of Device or Device Component
18
18
Mechanical Jam
15
15
Corroded
14
14
Crack
13
13
Scratched Material
12
12
Unintended Movement
10
10
Failure to Cut
9
9
No Apparent Adverse Event
4
4
Component Missing
4
4
Use of Device Problem
4
4
Contamination /Decontamination Problem
4
4
Compatibility Problem
4
4
Degraded
3
3
Structural Problem
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
Physical Resistance/Sticking
2
2
Failure to Calibrate
2
2
Appropriate Term/Code Not Available
2
2
Improper or Incorrect Procedure or Method
2
2
Unstable
2
2
Device Misassembled During Manufacturing /Shipping
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Difficult to Advance
1
1
Packaging Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Accessory Incompatible
1
1
Activation Failure
1
1
Connection Problem
1
1
Activation, Positioning or Separation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
600
600
No Consequences Or Impact To Patient
66
66
Insufficient Information
57
57
No Patient Involvement
31
31
No Known Impact Or Consequence To Patient
13
13
No Code Available
10
10
Foreign Body In Patient
5
5
No Information
4
4
Failure of Implant
2
2
Patient Problem/Medical Problem
1
1
Not Applicable
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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