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 Use of Device Problem (1670); Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994); Inadequate Osseointegration (2646); Patient Problem/Medical Problem (2688)
Date of Event 11/18/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The doctor reported that implant was removed due to failure of osseointegration, approximately five and half months after the implant placement date.Oral hygiene around the implant site was moderate.Bone quality at surgical site was type 3.During the surgery, patient complained of pain; however, patient has since 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 Key11106125
Report Number3005503242-2020-00221
Device Sequence Number3698713
Product Code DZE
UDI-Device IdentifierD755FX4508SWC0
UDI-PublicD755FX4508SWC0
Combination Product (Y/N)Y
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K160965
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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) 01/03/2021
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 12/09/2020
Initial Report FDA Received Date01/03/2021
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
-
-