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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wire, orthodontic
Product CodeDZC
Regulation Number 872.5410
Device Class 1


Premarket Reviews
ManufacturerDecision
ORMCO CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 2 2
2016 4 4
2017 1 1
2018 2 2
2019 6 6
2020 1 1
2021 3 3
2022 7 7
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6 6
Patient Device Interaction Problem 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Insufficient Information 3 3
Material Fragmentation 3 3
Inadequacy of Device Shape and/or Size 2 2
Patient-Device Incompatibility 2 2
Biocompatibility 1 1
Device Slipped 1 1
Migration or Expulsion of Device 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 6 6
Hypersensitivity/Allergic reaction 4 4
Device Embedded In Tissue or Plaque 4 4
No Information 3 3
No Code Available 3 3
Glossitis 1 1
Skin Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Unspecified Infection 1 1
Inflammation 1 1
Internal Organ Perforation 1 1
Reaction 1 1
Sensitivity of Teeth 1 1
No Known Impact Or Consequence To Patient 1 1
Abdominal Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Highland Metals, Inc. II Feb-03-2014
2 Ormco Corporation II Jan-11-2012
3 Ormco/Sybronendo II Nov-30-2015
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