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TPLC
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show TPLC since
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2024
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Device
bender
Product Code
HXW
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
4
4
2015
11
11
2016
30
30
2017
22
22
2018
43
43
2019
24
24
2020
16
16
2021
11
11
2022
10
10
2023
12
12
2024
19
19
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
60
60
Fracture
45
45
Material Deformation
27
27
Device Inoperable
16
16
Disassembly
15
15
Material Twisted/Bent
10
10
Detachment of Device or Device Component
8
8
Device-Device Incompatibility
8
8
Device Operates Differently Than Expected
6
6
Mechanical Jam
5
5
Sticking
4
4
Device Operational Issue
3
3
Physical Resistance/Sticking
3
3
Mechanical Problem
3
3
Naturally Worn
2
2
Device Slipped
2
2
Mechanics Altered
2
2
Loose or Intermittent Connection
2
2
Corroded
2
2
Degraded
2
2
Component Missing
1
1
Device Maintenance Issue
1
1
No Apparent Adverse Event
1
1
Device Or Device Fragments Location Unknown
1
1
Material Integrity Problem
1
1
Defective Device
1
1
Difficult to Open or Close
1
1
Migration or Expulsion of Device
1
1
Unintended Movement
1
1
Separation Failure
1
1
Difficult to Advance
1
1
Difficult to Remove
1
1
Failure To Adhere Or Bond
1
1
Material Fragmentation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
93
93
No Clinical Signs, Symptoms or Conditions
48
48
No Consequences Or Impact To Patient
34
34
No Code Available
7
7
No Information
7
7
No Patient Involvement
7
7
Sedation
2
2
Injury
1
1
Foreign Body In Patient
1
1
Nerve Damage
1
1
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap Implant Systems LLC
II
Jul-19-2022
2
Synthes, Inc.
II
Jan-28-2015
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