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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTIUM USA SUPERLINE; DENTAL IMPLANT
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DENTIUM USA SUPERLINE; DENTAL IMPLANT Back to Search Results
Model Number FX4012SWC
Medical Device Problem Codes Fracture (1260); Use of Device Problem (1670)
Health Effect - Clinical Codes Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Date of Event 01/29/2021
Type of Reportable Event Serious Injury
Event or Problem Description
The doctor reported that the implant was removed due implant fracture, approximately 5 years and 3 months after initial implant placement.Bone quality around the area was type 2, and oral hygiene around the implant was good.During the surgery, no significant findings were observed.Patient has since recovered.
 
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Brand Name
SUPERLINE
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
DENTIUM USA
6761 katella ave
cypress CA 90630
MDR Report Key11330553
Report Number3005503242-2020-00257
Device Sequence Number1151104
Product Code DZE
UDI-Device IdentifierD755FX4012SWC0
UDI-PublicD755FX4012SWC0
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K160965
Number of Events Summarized1
Summary Report (Y/N)Y
Device Implanted Year2015
Device Explanted Year2021
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) 02/15/2021
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 Health Professional
Device Expiration Date04/30/2023
Device Model NumberFX4012SWC
Device Catalogue NumberFX4012SWC
Device Lot NumberC17SA832S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/09/2021
Initial Report FDA Received Date02/15/2021
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 Age54 YR
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