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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 Code
NPM
Regulation Number
872.3930
Device Class
2
Premarket Reviews
Manufacturer
Decision
COLLAGEN MATRIX, INC.
SUBSTANTIALLY EQUIVALENT
2
DSM BIOMEDICAL
SUBSTANTIALLY EQUIVALENT
1
MEDPARK CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
PURGO BIOLOGICS INC.
SUBSTANTIALLY EQUIVALENT
1
SIGMAGRAFT INC.
SUBSTANTIALLY EQUIVALENT
1
WISHBONE SA
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
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
25
25
Adverse Event Without Identified Device or Use Problem
8
8
Osseointegration Problem
6
6
Failure to Osseointegrate
2
2
Physical Resistance/Sticking
2
2
Inaccurate Information
2
2
Biocompatibility
1
1
Material Disintegration
1
1
Off-Label Use
1
1
Use of Device Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Appropriate Term/Code Not Available
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
6
6
Failure of Implant
4
4
Implant Pain
4
4
No Clinical Signs, Symptoms or Conditions
3
3
Post Operative Wound Infection
3
3
Swelling/ Edema
3
3
Osteomyelitis
2
2
Inflammation
1
1
Foreign Body Reaction
1
1
Muscular Rigidity
1
1
No Code Available
1
1
Laceration(s)
1
1
No Patient Involvement
1
1
No Known Impact Or Consequence To Patient
1
1
Difficulty Chewing
1
1
Hematoma
1
1
Hypersensitivity/Allergic reaction
1
1
Unspecified Infection
1
1
Nerve Damage
1
1
Pain
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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