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 SUPERLINE; IMPLANT, ENDOSSEOUS, ROOT-FORM
  • 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 SUPERLINE; IMPLANT, ENDOSSEOUS, ROOT-FORM Back to Search Results
Model Number FX4308MLC
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event 07/18/2017
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant fx4014swc was removed on (b)(6) 2017 5 months after implantation due to failure to osseointegrate.The doctor indicated that local infection may have caused implant removal.The patient has no significant medical history and has been recovered without complications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SUPERLINE
Common Device Name
IMPLANT, ENDOSSEOUS, ROOT-FORM
Manufacturer (Section D)
DENTIUM USA
6761 katella ave
cypress CA 90630
MDR Report Key6810240
Report Number3005503242-2017-00051
Device Sequence Number969729
Product Code DZE
UDI-Device IdentifierD755FX4014SWC0
UDI-PublicD755FX4014SWC0
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K160965
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 08/22/2017
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 Date04/27/2024
Device Model NumberFX4308MLC
Device Catalogue NumberFX4308MLC
Device Lot NumberB21TA540S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/03/2017
Initial Report FDA Received Date08/22/2017
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 Age80 YR
-
-