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; 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 SUPERLINE; DENTAL IMPLANT Back to Search Results
Model Number FX4508SWC
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes Inadequate Osseointegration (2646); Patient Problem/Medical Problem (2688)
Date of Event 08/11/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The doctor reported the implant was removed due to osseointegration failure 9 months after placement surgery.Bone quality was type ii and oral hygiene at the site of the implant was moderate.During the surgery, periodontal disease was observed.The patient has recovered.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SUPERLINE
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
DENTIUM USA
6761 katella ave
cypress CA 90630
MDR Report Key10498293
Report Number3005503242-2020-00147
Device Sequence Number2627670
Product Code DZE
UDI-Device IdentifierD755FX4508SWC0
UDI-PublicD755FX4508SWC0
Combination Product (Y/N)Y
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K160965
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 09/06/2020
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 No Information
Device Model NumberFX4508SWC
Device Catalogue NumberFX4508SWC
Device Lot NumberK14PB368S
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/27/2020
Initial Report FDA Received Date09/06/2020
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 Age55 YR
-
-