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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
SMTP TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 34 34
2020 11 11
2021 7 7
2022 10 10
2023 5 5
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 34 34
Break 13 13
Fracture 9 9
Material Integrity Problem 3 3
Mechanical Problem 2 2
Energy Output Problem 2 2
Entrapment of Device 2 2
Defective Component 2 2
Device-Device Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Fire 1 1
Overheating of Device 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Packaging Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 18 18
No Code Available 18 18
No Clinical Signs, Symptoms or Conditions 16 16
Foreign Body In Patient 4 4
No Consequences Or Impact To Patient 4 4
Device Embedded In Tissue or Plaque 3 3
Insufficient Information 3 3
Oversedation 2 2
Pain 2 2
Discomfort 2 2
Burn, Thermal 1 1
No Patient Involvement 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer Biomet, Inc. II Jul-12-2019
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