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

MAUDE Adverse Event Report: DENTIUMUSA IMPLANTIUM; DENTAL IMPLANT
  • 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
 

DENTIUMUSA IMPLANTIUM; DENTAL IMPLANT Back to Search Results
Model Number FX3408MLC
Medical Device Problem Codes Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 10/02/2018
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant fx3408mlc was removed on (b)(6) 2018 due to loss of osseointegration around 9 years after implantation.The patient is a tobacco user and has history of bruxism and hypertension.The doctor noted bone resorption during explantation.The patient has recovered without complications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
IMPLANTIUM
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
DENTIUMUSA
6761 katella ave
cypress CA 90630
MDR Report Key8039003
Report Number3005503242-2018-00164
Device Sequence Number19228752
Product Code DZE
UDI-Device IdentifierD755FX3408MLC0
UDI-PublicD755FX3408MLC0
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K041368
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2009
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 11/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date11/30/2010
Device Model NumberFX3408MLC
Device Catalogue NumberFX3408MLC
Device Lot Number07K1902
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/30/2018
Initial Report FDA Received Date11/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age52 YR
-
-