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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
B&MEDI CO., LTD.
  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
2017 19 19
2018 14 14
2019 15 15
2020 5 5
2021 12 12
2022 6 6

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Osseointegration 21 21
Unspecified Infection 20 20
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
Insufficient Information 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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