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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
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
2019 10 10
2020 6 6
2021 6 6
2022 3 3
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 16 16
Failure to Osseointegrate 3 3
Device Appears to Trigger Rejection 2 2
Osseointegration Problem 2 2
Insufficient Information 1 1
Leak/Splash 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 6 6
Inflammation 5 5
Pain 3 3
Post Operative Wound Infection 3 3
No Clinical Signs, Symptoms or Conditions 3 3
No Known Impact Or Consequence To Patient 2 2
Inadequate Osseointegration 2 2
Swelling 2 2
Discomfort 1 1
Hypoesthesia 1 1
Impaired Healing 1 1
Reaction 1 1
Spinal Cord Injury 1 1
Paraplegia 1 1
Quadriplegia 1 1
Seroma 1 1
Spinal Column Injury 1 1
Itching Sensation 1 1
Muscle Weakness 1 1
Nerve Damage 1 1
Wound Dehiscence 1 1
Fever 1 1
Fistula 1 1
Bone Fracture(s) 1 1
Failure of Implant 1 1
Fluid Discharge 1 1

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