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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 FX4014SWC
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes Sinus Perforation (2277); Inadequate Osseointegration (2646)
Date of Event 06/17/2017
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant fx4014swc was removed due to loss of osseointegration 4 months after implantation.The doctor indicated patient had no significant medical history.Patient has been recovered without complication.
 
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Brand Name
SUPERLINE
Common Device Name
IMPLANT, ENDOSSEOUS, ROOT-FORM
Manufacturer (Section D)
DENTIUM USA
6761 katella ave
cypress CA 90630
MDR Report Key6750643
Report Number3005503242-2017-00025
Device Sequence Number220858
Product Code DZE
UDI-Device IdentifierD755FX4014SWC0
UDI-PublicD755FX4014SWC0
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K160965
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 07/27/2017
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 Date01/31/2023
Device Model NumberFX4014SWC
Device Catalogue NumberFX4014SWC
Device Lot NumberL31TA627S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/13/2017
Initial Report FDA Received Date07/28/2017
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;
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