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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, surgical, sonic and accessory/attachment
Product CodeJDX
Regulation Number 888.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
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
Entrapment of Device 2 2
Loss of Power 2 2
Energy Output Problem 2 2
Difficult to Remove 2 2
Device Sensing Problem 2 2
Device Remains Activated 1 1
Device-Device Incompatibility 1 1
Fire 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Disassembly 1 1
Failure to Calibrate 1 1
Intermittent Continuity 1 1
Mechanical Jam 1 1
Improper or Incorrect Procedure or Method 1 1
Device Displays Incorrect Message 1 1
Insufficient Information 1 1
Unintended Movement 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Detachment of Device or Device Component 1 1
Sticking 1 1
Unintended Power Up 1 1
Material Twisted/Bent 1 1
Packaging Problem 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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