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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
2018
26
26
2019
36
36
2020
24
24
2021
44
44
2022
37
37
2023
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
96
96
Material Integrity Problem
21
21
Fracture
17
17
Dull, Blunt
11
11
Failure to Cut
11
11
Mechanical Problem
5
5
Material Deformation
5
5
Crack
3
3
Device Operates Differently Than Expected
3
3
Mechanical Jam
3
3
Naturally Worn
3
3
Contamination /Decontamination Problem
2
2
Material Fragmentation
2
2
Material Frayed
1
1
Corroded
1
1
Delivered as Unsterile Product
1
1
Component Missing
1
1
Defective Device
1
1
Detachment of Device or Device Component
1
1
Difficult to Open or Close
1
1
Material Twisted/Bent
1
1
Packaging Problem
1
1
No Apparent Adverse Event
1
1
Physical Resistance/Sticking
1
1
Device Fell
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
89
89
No Consequences Or Impact To Patient
38
38
No Patient Involvement
19
19
No Known Impact Or Consequence To Patient
15
15
No Code Available
7
7
No Information
3
3
Insufficient Information
2
2
Foreign Body In Patient
2
2
Tissue Damage
1
1
Brain Injury
1
1
Spinal Cord Injury
1
1
Alteration In Body Temperature
1
1
Laceration(s)
1
1
Weakness
1
1
Blood Loss
1
1
Device Embedded In Tissue or Plaque
1
1
Hemorrhage/Bleeding
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Zimmer Biomet, Inc.
II
Dec-22-2020
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