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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTIUM USA SUPERLINE; IMPLANT, ENDOSSEOUS, ROOT-FORM
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DENTIUM USA SUPERLINE; IMPLANT, ENDOSSEOUS, ROOT-FORM Back to Search Results
Model Number FX6012SWC
Medical Device Problem Codes Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event 01/20/2017
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant, fx6012swc was removed on (b)(6) 2017 due to loss of osseointegration 1 year and 6 months after implantation.The doctor indicated that local infection and pain caused the implant removal.The patient has no medical history.The patient has been recovered.
 
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Brand Name
SUPERLINE
Common Device Name
IMPLANT, ENDOSSEOUS, ROOT-FORM
Manufacturer (Section D)
DENTIUM USA
6761 katella avenue
cypress CA 90630
MDR Report Key6603651
Report Number3005503242-2017-00014
Device Sequence Number649997
Product Code DZE
UDI-Device IdentifierD755FX6012SWC0
UDI-PublicD755FX6012SWC0
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K160965
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 05/31/2017
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 Dentist
Device Expiration Date09/30/2020
Device Model NumberFX6012SWC
Device Lot NumberI18VA379S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/22/2017
Initial Report FDA Received Date05/31/2017
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 Age51 YR
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