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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
3
3
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
Burst Container or Vessel
7
7
Overheating of Device
7
7
Noise, Audible
5
5
Device Inoperable
5
5
Device-Device Incompatibility
5
5
Fracture
4
4
Detachment Of Device Component
3
3
Excessive Heating
3
3
Mechanical Jam
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Output below Specifications
2
2
Partial Blockage
2
2
Use of Device Problem
2
2
Vibration
2
2
Material Deformation
2
2
Material Integrity Problem
1
1
Sticking
1
1
Expulsion
1
1
Improper Flow or Infusion
1
1
Maintenance Does Not Comply To Manufacturers Recommendations
1
1
Hole In Material
1
1
Mechanical Problem
1
1
Device Displays Incorrect Message
1
1
Contamination /Decontamination Problem
1
1
Connection Problem
1
1
Fitting Problem
1
1
Defective Component
1
1
Component Missing
1
1
Dull, Blunt
1
1
Failure to Align
1
1
Fluid/Blood Leak
1
1
Component Falling
1
1
Intermittent Continuity
1
1
Crack
1
1
Disassembly
1
1
Power Problem
1
1
Temperature Problem
1
1
Unintended Movement
1
1
No Apparent Adverse Event
1
1
Insufficient Information
1
1
Naturally Worn
1
1
Physical Resistance/Sticking
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
86
86
No Known Impact Or Consequence To Patient
54
54
No Consequences Or Impact To Patient
28
28
No Patient Involvement
18
18
Foreign Body In Patient
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
Foreign Body Reaction
1
1
Laceration(s)
1
1
Superficial (First Degree) Burn
1
1
Hearing Impairment
1
1
Unspecified Infection
1
1
Pain
1
1
Tinnitus
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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