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TPLC
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show TPLC since
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Device
instrument, bending or contouring
Product Code
HXP
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
10
10
2015
14
14
2016
8
8
2017
3
3
2018
4
4
2019
4
4
2020
10
10
2021
19
19
2022
11
11
2023
5
5
2024
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
51
51
Device-Device Incompatibility
12
12
Mechanical Problem
10
10
Device Operates Differently Than Expected
7
7
Adverse Event Without Identified Device or Use Problem
5
5
Connection Problem
3
3
Sticking
2
2
Mechanical Jam
2
2
Corroded
2
2
Compatibility Problem
1
1
Crack
1
1
Material Fragmentation
1
1
Failure to Align
1
1
Component Missing
1
1
Bent
1
1
Material Deformation
1
1
Difficult to Open or Close
1
1
Device Inoperable
1
1
Loose or Intermittent Connection
1
1
Fracture
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
42
42
No Known Impact Or Consequence To Patient
21
21
No Patient Involvement
17
17
No Consequences Or Impact To Patient
10
10
Insufficient Information
4
4
Post Operative Wound Infection
2
2
Not Applicable
1
1
No Code Available
1
1
No Information
1
1
Blood Loss
1
1
Injury
1
1
Swelling
1
1
Pain
1
1
Sedation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Synthes USA HQ, Inc.
II
Nov-26-2013
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