• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
2017 10 10
2018 3 3
2019 10 10
2020 6 6
2021 6 6

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 3 3
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
Insufficient Information 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
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
Failure of Implant 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
No Information 1 1
Wound Dehiscence 1 1

-
-