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 Code	NUN
Regulation Number	872.3930
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	8	8
Leak/Splash	2	2
Osseointegration Problem	2	2
Insufficient Device Problem Information	1	1
Contamination /Decontamination Problem	1	1
Off-Label Use	1	1
Failure to Osseointegrate	1	1
Packaging Problem	1	1
Delivered as Unsterile Product	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
Failure of Implant	3	3
Nerve Damage	2	2
Inflammation	2	2
Bacterial Infection	1	1
Burning Sensation	1	1
Ambulation or Postural Difficulties	1	1
Bone Fracture(s)	1	1
Fluid Discharge	1	1
Muscle Weakness/Atrophy	1	1
Paraplegia	1	1
Spinal Cord Injury	1	1
Anaphylactic Shock	1	1
Impaired Healing	1	1
Numbness	1	1
Extravasation	1	1
Hypoesthesia	1	1
Extraskeletal ossification	1	1
Spinal Column Injury	1	1
Peripheral Nervous Injury	1	1