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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, animal source
Regulation Description Bone grafting material.
Definition A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.
Product CodeNPM
Regulation Number 872.3930
Device Class 2


Premarket Reviews
ManufacturerDecision
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 5
DATUM DENTAL LTD
  SUBSTANTIALLY EQUIVALENT 1
DSM BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HIOSSEN INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTITUT STRAUMANN AG
  SUBSTANTIALLY EQUIVALENT 1
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PURGO BIOLOGICS INC.
  SUBSTANTIALLY EQUIVALENT 2
WISHBONE SA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 3 3
2018 8 8
2019 6 6
2020 3 3
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Osseointegrate 9 9
Adverse Event Without Identified Device or Use Problem 7 7
Insufficient Information 6 6
Physical Resistance/Sticking 2 2
Inaccurate Information 1 1
Appropriate Term/Code Not Available 1 1
Osseointegration Problem 1 1
Patient-Device Incompatibility 1 1
Material Disintegration 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Osseointegration 7 7
Failure of Implant 4 4
Inflammation 4 4
Complaint, Ill-Defined 4 4
Post Operative Wound Infection 4 4
No Clinical Signs, Symptoms or Conditions 2 2
Foreign Body Reaction 1 1
No Patient Involvement 1 1
Nerve Damage 1 1
Unspecified Infection 1 1
No Known Impact Or Consequence To Patient 1 1
Fibrosis 1 1
No Code Available 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Collagen Matrix Inc III Jan-17-2019
2 Collagen Matrix Inc III Mar-15-2016
3 Collagen Matrix Inc II Mar-11-2016
4 Collagen Matrix Inc II Mar-11-2016
5 Geistlich Pharma North America, Inc. II Nov-25-2020
6 Geistlich Pharma North America, Inc. II Aug-02-2019
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