Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Definition Pma approved: P000054
Product CodeMPW
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
3 4 2 6 7 0 2 1 4 2 6 4 3 4 3 0

MDR Year MDR Reports MDR Events
2015 10 10
2017 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9 9
Break 2 2
Loose or Intermittent Connection 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2 2
Ischemia Stroke 1 1
Malunion of Bone 1 1
Chest Pain 1 1
Eye Injury 1 1
Fatigue 1 1
Bone Fracture(s) 1 1
Unspecified Infection 1 1
Pain 1 1
Swelling 1 1
Concussion 1 1
Dizziness 1 1
Anxiety 1 1
Complaint, Ill-Defined 1 1
Joint Disorder 1 1
Collapse 1 1
Post Operative Wound Infection 1 1
Sleep Dysfunction 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1

-
-