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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instruments, dental hand
Product CodeDZN
Regulation Number 872.4565
Device Class 1


Premarket Reviews
ManufacturerDecision
KERRHAWE SA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 76 76
2015 51 51
2016 30 30
2017 17 17
2018 9 9
2019 12 12
2020 15 15
2021 21 21
2022 26 26
2023 38 38
2024 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Break 284 284
Peeled/Delaminated 5 5
Flaked 5 5
Material Integrity Problem 5 5
Bent 4 4
Adverse Event Without Identified Device or Use Problem 2 2
Separation Failure 2 2
Detachment of Device or Device Component 2 2
Device Operates Differently Than Expected 2 2
Component Incompatible 2 2
Crack 1 1
Detachment Of Device Component 1 1
Material Separation 1 1
Problem with Sterilization 1 1
Unraveled Material 1 1
Failure to Osseointegrate 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Damaged by Another Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Patient-Device Incompatibility 1 1
Material Fragmentation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 151 151
No Clinical Signs, Symptoms or Conditions 88 88
No Known Impact Or Consequence To Patient 54 54
Insufficient Information 24 24
No Information 11 11
No Patient Involvement 7 7
Foreign Body In Patient 3 3
Device Embedded In Tissue or Plaque 3 3
Tooth Fracture 2 2
Needle Stick/Puncture 1 1
Injury 1 1
Erythema 1 1
Bone Fracture(s) 1 1
Hypersensitivity/Allergic reaction 1 1
Failure of Implant 1 1
Laceration(s) 1 1
Pain 1 1
Tissue Damage 1 1
No Code Available 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ormco/Sybronendo II Nov-05-2012
2 Ultradent Products, Inc. II Jan-05-2016
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