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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 FX5012SWC
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 06/14/2018
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant fx5012swc was removed on (b)(6) 2018 due to failure to osseointegrate 6 months and 2 days after implantation.The patient has no significant medical history.The patient required another surgical intervention.
 
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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 Key7682061
Report Number3005503242-2018-00119
Device Sequence Number19175000
Product Code DZE
UDI-Device IdentifierD755FX5012SWC0
UDI-PublicD755FX5012SWC0
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 Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 07/12/2018
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 Date10/26/2024
Device Model NumberFX5012SWC
Device Catalogue NumberFX5012SWC
Device Lot NumberH30RA937S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/05/2018
Initial Report FDA Received Date07/12/2018
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 Age49 YR
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