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TPLC
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show TPLC since
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Device
instrument, surgical, sonic and accessory/attachment
Product Code
JDX
Regulation Number
888.4580
Device Class
2
Premarket Reviews
Manufacturer
Decision
MECTRON S.P.A.
SUBSTANTIALLY EQUIVALENT
1
MECTRON SPA
SUBSTANTIALLY EQUIVALENT
1
MORLEY RESEARCH CONSORTIUM
SUBSTANTIALLY EQUIVALENT
1
ORTHOSONICS, LTD.
SUBSTANTIALLY EQUIVALENT
2
PIEZOSURGERY SRL
SUBSTANTIALLY EQUIVALENT
1
SATALEC-ACTEON GROUP
SUBSTANTIALLY EQUIVALENT
1
SATELEC
SUBSTANTIALLY EQUIVALENT
1
SMTP TECHNOLOGY CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
16
16
2015
6
6
2016
4
4
2017
8
8
2018
42
42
2019
34
34
2020
11
11
2021
7
7
2022
10
10
2023
5
5
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Electrical /Electronic Property Problem
43
43
Break
21
21
Fracture
19
19
Device Inoperable
13
13
Mechanical Problem
12
12
Material Integrity Problem
11
11
Overheating of Device
6
6
Defective Component
3
3
Device Operates Differently Than Expected
3
3
Device Stops Intermittently
3
3
Device Sensing Problem
2
2
Loss of Power
2
2
Entrapment of Device
2
2
Energy Output Problem
2
2
Difficult to Remove
2
2
Sticking
1
1
Detachment of Device or Device Component
1
1
Mechanical Jam
1
1
Improper or Incorrect Procedure or Method
1
1
Device Displays Incorrect Message
1
1
Device-Device Incompatibility
1
1
Device Remains Activated
1
1
Fire
1
1
Unintended Power Up
1
1
Insufficient Information
1
1
Unintended Movement
1
1
Defective Device
1
1
Disassembly
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Packaging Problem
1
1
Failure to Calibrate
1
1
Intermittent Continuity
1
1
Material Twisted/Bent
1
1
Noise, Audible
1
1
Temperature Problem
1
1
Detachment Of Device Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
44
44
No Code Available
40
40
No Clinical Signs, Symptoms or Conditions
17
17
No Consequences Or Impact To Patient
13
13
No Information
11
11
Foreign Body In Patient
7
7
No Patient Involvement
5
5
Device Embedded In Tissue or Plaque
5
5
Oversedation
4
4
Insufficient Information
3
3
Pain
3
3
Discomfort
2
2
Patient Problem/Medical Problem
1
1
Burn, Thermal
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Zimmer Biomet, Inc.
II
Jul-12-2019
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