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U.S. Department of Health and Human Services

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
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
2017 19 19
2018 14 14
2019 15 15
2020 5 5
2021 12 12
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 16 16
Failure to Osseointegrate 15 15
Adverse Event Without Identified Device or Use Problem 14 14
Patient-Device Incompatibility 8 8
Product Quality Problem 4 4
Device Emits Odor 3 3
Device Operates Differently Than Expected 2 2
Patient Device Interaction Problem 2 2
Appropriate Term/Code Not Available 2 2
Loss of or Failure to Bond 1 1
Shelf Life Exceeded 1 1
Device Markings/Labelling Problem 1 1
Material Separation 1 1
Device Appears to Trigger Rejection 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of Osseointegration 1 1
Osseointegration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Osseointegration 21 21
Unspecified Infection 19 19
Pain 14 14
Inflammation 9 9
Irritation 9 9
Burning Sensation 8 8
Reaction 6 6
Failure of Implant 4 4
Sensitivity of Teeth 4 4
Foreign Body Reaction 4 4
Hypersensitivity/Allergic reaction 3 3
Swelling 3 3
Injury 2 2
Wound Dehiscence 2 2
Host-Tissue Reaction 2 2
Abscess 2 2
Non-union Bone Fracture 2 2
Foreign Body In Patient 2 2
No Information 2 2
Implant Pain 2 2
Swelling/ Edema 1 1
Osteolysis 1 1
Impaired Healing 1 1
Numbness 1 1
Debris, Bone Shedding 1 1
Edema 1 1
Necrosis 1 1
Hypoesthesia 1 1
Dizziness 1 1
No Consequences Or Impact To Patient 1 1
Tinnitus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Collagen Matrix, Inc. III Nov-09-2018
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