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TPLC - Total Product Life Cycle
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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
2019
36
36
2020
24
24
2021
44
44
2022
37
37
2023
33
33
2024
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
100
100
Material Integrity Problem
29
29
Failure to Cut
13
13
Fracture
11
11
Dull, Blunt
10
10
Material Deformation
6
6
Mechanical Problem
5
5
Crack
3
3
Naturally Worn
3
3
Material Fragmentation
3
3
Contamination /Decontamination Problem
3
3
Adverse Event Without Identified Device or Use Problem
2
2
Activation, Positioning or Separation Problem
2
2
No Apparent Adverse Event
1
1
Difficult to Open or Close
1
1
Component Missing
1
1
Material Frayed
1
1
Material Twisted/Bent
1
1
Device Fell
1
1
Compatibility Problem
1
1
Corroded
1
1
Mechanical Jam
1
1
Device-Device Incompatibility
1
1
Physical Resistance/Sticking
1
1
Defective Device
1
1
Device Slipped
1
1
Packaging Problem
1
1
Detachment of Device or Device Component
1
1
Flaked
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
119
119
No Consequences Or Impact To Patient
28
28
No Patient Involvement
15
15
No Known Impact Or Consequence To Patient
9
9
Insufficient Information
6
6
Foreign Body In Patient
5
5
No Information
3
3
No Code Available
3
3
Hemorrhage/Bleeding
1
1
Laceration(s)
1
1
Tissue Damage
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Zimmer Biomet, Inc.
II
Dec-22-2020
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