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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 FX4512SWC
Medical Device Problem Codes Use of Device Problem (1670); Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes Failure of Implant (1924); Inadequate Osseointegration (2646); Patient Problem/Medical Problem (2688)
Date of Event 12/02/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The doctor reported that the implant was removed due to loss of osseointegration 4 years and 9 months after initial implant placement.Bone quality around the area was type 2, and oral hygiene around the implant was moderate.During the surgery, bone resorption and periodontal disease 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 Key11330557
Report Number3005503242-2020-00256
Device Sequence Number11050550
Product Code DZE
UDI-Device IdentifierD755FX4512SWC0
UDI-PublicD755FX4512SWC0
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 Year2016
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) 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 Date12/03/2023
Device Model NumberFX4512SWC
Device Catalogue NumberFX4512SWC
Device Lot NumberH31SA868S
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 Age52 YR
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