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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 FX6012SWC
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes Unspecified Infection (1930); Inadequate Osseointegration (2646); Patient Problem/Medical Problem (2688)
Date of Event 07/20/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The doctor reported the implant was removed due to osseointegration failure 4 months after placement surgery.Bone quality was type ii and oral hygiene at the site of the implant was good.During the surgery, local infection was observed.
 
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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 Key10524091
Report Number3005503242-2020-00154
Device Sequence Number11564119
Product Code DZE
UDI-Device IdentifierD755FX6012SWC0
UDI-PublicD755FX6012SWC0
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) 09/11/2020
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 Expiration Date03/02/2025
Device Model NumberFX6012SWC
Device Catalogue NumberFX6012SWC
Device Lot NumberC01QB006S
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/09/2020
Initial Report FDA Received Date09/11/2020
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 Age44 YR
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