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TPLC - Total Product Life Cycle
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Device bone grafting material, synthetic
Definition A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.
Product CodeLYC
Regulation Number 872.3930
Device Class 2


Premarket Reviews
ManufacturerDecision
DIMENSION INX CORP.
  SUBSTANTIALLY EQUIVALENT 1
GC AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTITUT STRAUMANN AG
  SUBSTANTIALLY EQUIVALENT 1
OSTEOGENE TECH CORP
  SUBSTANTIALLY EQUIVALENT 1
REVISIOS BV
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 15 15
2020 5 5
2021 12 12
2022 6 6
2023 9 9
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Osseointegrate 12 12
Adverse Event Without Identified Device or Use Problem 9 9
Insufficient Information 7 7
Patient-Device Incompatibility 7 7
Product Quality Problem 4 4
Device Emits Odor 3 3
Appropriate Term/Code Not Available 2 2
Patient Device Interaction Problem 2 2
Osseointegration Problem 1 1
Loss of or Failure to Bond 1 1
Contamination 1 1
Device Markings/Labelling Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of Osseointegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Osseointegration 17 17
Pain 15 15
Unspecified Infection 9 9
Inflammation 9 9
Foreign Body Reaction 4 4
Sensitivity of Teeth 4 4
Hypersensitivity/Allergic reaction 3 3
Implant Pain 3 3
Failure of Implant 2 2
Foreign Body In Patient 2 2
Swelling 2 2
Non-union Bone Fracture 2 2
Swelling/ Edema 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Wound Dehiscence 1 1
Debris, Bone Shedding 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Necrosis 1 1
Dizziness 1 1
Skin Inflammation/ Irritation 1 1
Edema 1 1
Rash 1 1
Burning Sensation 1 1
Numbness 1 1
Insufficient Information 1 1
Abscess 1 1
Reaction 1 1
Tinnitus 1 1
No Consequences Or Impact To Patient 1 1
Hypoesthesia 1 1

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