TPLC - Total Product Life Cycle

• 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 Code: NUN
• Regulation Number: 872.3930
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2021	6	6
2022	3	3
2024	2	2
2025	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	6	6
Leak/Splash	2	2
Osseointegration Problem	2	2
Off-Label Use	1	1
Insufficient Information	1	1
Contamination /Decontamination Problem	1	1
Failure to Osseointegrate	1	1
Delivered as Unsterile Product	1	1
Packaging Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6	6
Pain	4	4
Inflammation	2	2
Nerve Damage	2	2
Impaired Healing	1	1
Failure of Implant	1	1
Bone Fracture(s)	1	1
Muscle Weakness	1	1
Spinal Column Injury	1	1
Ossification	1	1
Burning Sensation	1	1
Numbness	1	1
Peripheral Nervous Injury	1	1
Fluid Discharge	1	1
Extravasation	1	1
Anaphylactic Shock	1	1
Paraplegia	1	1
Hypoesthesia	1	1
Bacterial Infection	1	1
Spinal Cord Injury	1	1
Ambulation Difficulties	1	1