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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 12/13/2017
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant fx5012swc was removed on (b)(6) 2017 due to failure to osseointegrate 1 month and 7 days after implantation.The the doctor indicated that dental hygiene around the implant was poor and bone quality was type iii.The patient has no significant medical history and will require additional 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 Key7186266
Report Number3005503242-2018-00002
Device Sequence Number11065874
Product Code DZE
UDI-Device IdentifierD755FX5012SWC0
UDI-PublicD755FX5012SWC0
Combination Product (Y/N)N
Initial Reporter StateNY
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) 01/12/2018
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 Dentist
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 Manufacturer12/18/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/18/2017
Initial Report FDA Received Date01/12/2018
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 Age50 YR
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