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TPLC
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show TPLC since
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2024
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Device
instrument, surgical, orthopedic, pneumatic powered & accessory/attachment
Product Code
HSZ
Regulation Number
878.4820
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
18
18
2015
20
20
2016
27
27
2017
24
24
2018
13
13
2019
5
5
2020
13
13
2021
27
27
2022
35
35
2023
39
39
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
86
86
Failure to Cut
25
25
Air Leak
22
22
Material Rupture
21
21
Entrapment of Device
17
17
Leak/Splash
13
13
Device Operates Differently Than Expected
9
9
Overheating of Device
8
8
Burst Container or Vessel
7
7
Noise, Audible
5
5
Device-Device Incompatibility
5
5
Device Inoperable
5
5
Fracture
4
4
Excessive Heating
3
3
Detachment Of Device Component
3
3
Vibration
2
2
Use of Device Problem
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Material Deformation
2
2
Partial Blockage
2
2
Mechanical Jam
2
2
Output below Specifications
2
2
Material Integrity Problem
1
1
Defective Component
1
1
Contamination /Decontamination Problem
1
1
Disassembly
1
1
Improper Flow or Infusion
1
1
Failure to Align
1
1
Component Missing
1
1
Insufficient Information
1
1
Unintended Movement
1
1
Sticking
1
1
No Apparent Adverse Event
1
1
Crack
1
1
Physical Resistance/Sticking
1
1
Power Problem
1
1
Maintenance Does Not Comply To Manufacturers Recommendations
1
1
Connection Problem
1
1
Intermittent Continuity
1
1
Naturally Worn
1
1
Mechanical Problem
1
1
Fitting Problem
1
1
Device Displays Incorrect Message
1
1
Component Falling
1
1
Hole In Material
1
1
Temperature Problem
1
1
Expulsion
1
1
Dull, Blunt
1
1
Fluid/Blood Leak
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
87
87
No Known Impact Or Consequence To Patient
54
54
No Consequences Or Impact To Patient
28
28
Foreign Body In Patient
18
18
No Patient Involvement
18
18
No Code Available
6
6
Insufficient Information
6
6
No Information
5
5
Device Embedded In Tissue or Plaque
3
3
Burn(s)
2
2
Superficial (First Degree) Burn
1
1
Tinnitus
1
1
Laceration(s)
1
1
Foreign Body Reaction
1
1
Hearing Impairment
1
1
Pain
1
1
Unspecified Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Synthes (USA) Products LLC
II
Mar-01-2024
2
The Anspach Effort, Inc.
II
May-04-2017
3
The Anspach Effort, Inc.
II
Jul-03-2014
4
The Anspach Effort, Inc.
II
Jan-09-2014
5
The Anspach Effort, Inc.
II
Nov-13-2013
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