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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 2
COLLAGEN SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DSM BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GEISTLICH PHARMA AG
  SUBSTANTIALLY EQUIVALENT 4
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
2020 3 3
2021 4 4
2022 27 27
2023 4 4
2024 5 5
2025 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 26 26
Adverse Event Without Identified Device or Use Problem 9 9
Osseointegration Problem 6 6
Patient-Device Incompatibility 4 4
Failure to Osseointegrate 3 3
Physical Resistance/Sticking 2 2
Lack of Effect 2 2
Therapeutic or Diagnostic Output Failure 1 1
Use of Device Problem 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Device Appears to Trigger Rejection 1 1
Inaccurate Information 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Hypersensitivity/Allergic reaction 6 6
Inadequate Osseointegration 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Implant Pain 5 5
Unspecified Infection 4 4
Failure of Implant 4 4
Post Operative Wound Infection 3 3
Insufficient Information 3 3
Swelling/ Edema 3 3
Foreign Body Reaction 2 2
Osteomyelitis 2 2
Difficulty Chewing 1 1
Hematoma 1 1
Inflammation 1 1
Cellulitis 1 1
Hepatitis 1 1
Muscular Rigidity 1 1
Laceration(s) 1 1
Pain 1 1
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ace Surgical Supply Co., Inc. II Mar-24-2022
2 Geistlich Pharma North America, Inc. II Nov-25-2020
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