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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 FX4514SWC
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 08/23/2017
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant fx4514swc was removed on (b)(6) 2017 due to failure to osseointegrate 4 months and 11 days after implantation.The doctor indicated that bone resorption may have caused the implant removal.The patient had a history of hypertension and tobacco use and has been recovered without complication.
 
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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 Key7050421
Report Number3005503242-2017-00129
Device Sequence Number11059335
Product Code DZE
UDI-Device IdentifierD755FX4514SWC0
UDI-PublicD755FX4514SWC0
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 Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 11/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Operator of Device No Information
Device Expiration Date01/10/2024
Device Model NumberFX4514SWC
Device Catalogue NumberFX4514SWC
Device Lot NumberA07RA989S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/06/2017
Initial Report FDA Received Date11/21/2017
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 Age67 YR
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