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TPLC
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show TPLC since
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Device
cutter, wire
Product Code
HXZ
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
29
29
2015
24
24
2016
33
33
2017
25
25
2018
26
26
2019
36
36
2020
24
24
2021
44
44
2022
37
37
2023
33
33
2024
25
25
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
198
198
Material Integrity Problem
32
32
Fracture
23
23
Material Fragmentation
15
15
Failure to Cut
14
14
Dull, Blunt
14
14
Material Deformation
8
8
Device Operates Differently Than Expected
8
8
Mechanical Problem
6
6
Component Missing
6
6
Device Inoperable
4
4
Crack
4
4
Contamination /Decontamination Problem
4
4
Mechanical Jam
3
3
Naturally Worn
3
3
Detachment of Device or Device Component
3
3
Device Slipped
3
3
Adverse Event Without Identified Device or Use Problem
2
2
Flaked
2
2
Activation, Positioning or Separation Problem
2
2
Appropriate Term/Code Not Available
1
1
Component Falling
1
1
Bent
1
1
Delamination
1
1
Packaging Problem
1
1
Material Twisted/Bent
1
1
Delivered as Unsterile Product
1
1
Tip breakage
1
1
No Apparent Adverse Event
1
1
Material Frayed
1
1
Device-Device Incompatibility
1
1
Corroded
1
1
Physical Resistance/Sticking
1
1
Device Operational Issue
1
1
Leak/Splash
1
1
Device Fell
1
1
Insufficient Information
1
1
Compatibility Problem
1
1
Expiration Date Error
1
1
Defective Device
1
1
Device Expiration Issue
1
1
Difficult to Open or Close
1
1
Pressure Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
128
128
No Known Impact Or Consequence To Patient
73
73
No Consequences Or Impact To Patient
54
54
No Patient Involvement
52
52
No Code Available
12
12
Insufficient Information
9
9
No Information
8
8
Foreign Body In Patient
8
8
Device Embedded In Tissue or Plaque
2
2
Brain Injury
1
1
Blood Loss
1
1
Alteration In Body Temperature
1
1
Weakness
1
1
Laceration(s)
1
1
Tissue Damage
1
1
Hemorrhage/Bleeding
1
1
Spinal Cord Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Zimmer Biomet, Inc.
II
Dec-22-2020
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