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 SUPERLINE; 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 SUPERLINE; DENTAL IMPLANT Back to Search Results
Model Number FX6012SWC
Medical Device Problem Codes Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 03/19/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
The dental implant fx6012swc was removed on (b)(6) 2019 due to loss of osseointegration 3 years and 5 months after implantation.The patient has history of tobacco use.The doctor noted periodontal disease and sinus perforation during explantation.The patient has recovered without complications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SUPERLINE
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
DENTIUMUSA
6761 katella ave
cypress CA 90630
MDR Report Key8600464
Report Number3005503242-2019-00065
Device Sequence Number2010521
Product Code DZE
UDI-Device IdentifierD755FX6012SWC0
UDI-PublicD755FX6012SWC0
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K160965
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 05/10/2019
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 Date09/30/2020
Device Model NumberFX6012SWC
Device Catalogue NumberFX6012SWC
Device Lot NumberI18VA379S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/30/2019
Initial Report FDA Received Date05/10/2019
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 Age58 YR
-
-