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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 FX6010SWC
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 07/05/2017
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant fx6010swc fell out of the site on (b)(6) 2017 due to failure to osseointegrate approximately 3 months after implantation.The patient had no significant medical history and will require 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 Key6978486
Report Number3005503242-2017-00108
Device Sequence Number1599824
Product Code DZE
UDI-Device IdentifierD755FX6010SWC0
UDI-PublicD755FX6010SWC0
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) 10/25/2017
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 Date10/21/2023
Device Model NumberFX6010SWC
Device Catalogue NumberFX6010SWC
Device Lot NumberI08SA668S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/10/2017
Initial Report FDA Received Date10/25/2017
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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