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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, human source
Regulation Description Bone grafting material.
Definition INTENDED TO BE PACKED INTO BONY VOIDS OR GAPS TO FILL AND/OR AUGMENT DENTAL INTRAOSSEOUS, ORAL AND CRANIO-/MAXILLOFACIAL DEFECTS. THESE DEFECTS MAY BE SURGICALLY CREATD OSSEOUS DEFECTS OR OSSEOUS DEFECTS CREATED FROM TRAUMATIC INJRY TO THE BONE, INLCUDING PERIODENTA/INFRABONY DEFECTS; ALVEOLAR RIDGE AUGMENTATION (SINUSOTOMY, OSTEOTOMY, CYSTECTOMY); DENTAL EXTRACTION SITES (RIDGE MAINTENANCE, IMPLANT PREPARATION/PLACEMENT); SINUS LIFTS; CYSTIC DEFECTS; CRANIOFACIAL AUGMENTATION.
Product CodeNUN
Regulation Number 872.3930
Device Class 2

MDR Year MDR Reports MDR Events
2016 1 1
2017 10 10
2018 3 3
2019 10 10
2020 6 6
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 22 22
Appropriate Term/Code Not Available 5 5
Failure to Osseointegrate 2 2
Insufficient Information 2 2
Device Appears to Trigger Rejection 2 2
Use of Device Problem 1 1
Failure To Adhere Or Bond 1 1
Device Expiration Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 10 10
Unspecified Infection 6 6
Inflammation 5 5
Swelling 5 5
Post Operative Wound Infection 3 3
No Known Impact Or Consequence To Patient 3 3
No Information 2 2
Inadequate Osseointegration 2 2
Reaction 2 2
Skin Discoloration 2 2
Rheumatoid Arthritis 2 2
Autoimmune Disorder 2 2
Fever 1 1
Fistula 1 1
Bone Fracture(s) 1 1
Herpes 1 1
Itching Sensation 1 1
Nerve Damage 1 1
Spinal Column Injury 1 1
Seroma 1 1
Numbness 1 1
Spinal Cord Injury 1 1
Discomfort 1 1
Impaired Healing 1 1
Fluid Discharge 1 1
Paraplegia 1 1
Quadriplegia 1 1
Wound Dehiscence 1 1

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