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: DENTIUM USA 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
 

DENTIUM USA IMPLANTIUM; DENTAL IMPLANT Back to Search Results
Model Number FX4308MLC
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 03/05/2018
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant fx4308mlc was removed on (b)(6) 2018 due to failure to osseointegrate 1 month and 5 days after implantation.The doctor noted sinus perforation during the surgery.The patient is a tobacco user but has no other significant medical history.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)
DENTIUM USA
6761 katella ave
cypress CA 90630
MDR Report Key7617512
Report Number3005503242-2018-00092
Device Sequence Number1799876
Product Code DZE
UDI-Device IdentifierD755FX4308MLC0
UDI-PublicD755FX4308MLC0
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 Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 06/19/2018
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 Dentist
Device Expiration Date07/31/2023
Device Model NumberFX4308MLC
Device Catalogue NumberFX4308MLC
Device Lot NumberF15SA961S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/25/2018
Initial Report FDA Received Date06/19/2018
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 Age46 YR
-
-