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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
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
INSTITUT STRAUMANN AG
  SUBSTANTIALLY EQUIVALENT 1
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDPARK CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PURGO BIOLOGICS INC.
  SUBSTANTIALLY EQUIVALENT 2
SIGMAGRAFT INC.
  SUBSTANTIALLY EQUIVALENT 1
WISHBONE SA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 3 3
2018 8 8
2019 6 6
2020 3 3
2021 4 4
2022 27 27
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 26 26
Failure to Osseointegrate 10 10
Adverse Event Without Identified Device or Use Problem 9 9
Osseointegration Problem 6 6
Physical Resistance/Sticking 2 2
Inaccurate Information 2 2
Therapeutic or Diagnostic Output Failure 1 1
Appropriate Term/Code Not Available 1 1
Patient-Device Incompatibility 1 1
Biocompatibility 1 1
Material Disintegration 1 1
Off-Label Use 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Inadequate Osseointegration 11 11
Failure of Implant 7 7
Inflammation 4 4
Complaint, Ill-Defined 4 4
Implant Pain 4 4
Swelling/ Edema 3 3
Post Operative Wound Infection 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Osteomyelitis 2 2
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1
Fibrosis 1 1
No Code Available 1 1
Difficulty Chewing 1 1
Laceration(s) 1 1
Muscular Rigidity 1 1
Nerve Damage 1 1
Pain 1 1
Unspecified Infection 1 1
Foreign Body Reaction 1 1
Hematoma 1 1
Hypersensitivity/Allergic reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ace Surgical Supply Co., Inc. II Mar-24-2022
2 Collagen Matrix Inc III Jan-17-2019
3 Geistlich Pharma North America, Inc. II Nov-25-2020
4 Geistlich Pharma North America, Inc. II Aug-02-2019
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