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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTIUMUSA SUPERLINE; DENTAL IMPLANT
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DENTIUMUSA SUPERLINE; DENTAL IMPLANT Back to Search Results
Model Number FX6008SWC
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event 05/06/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
The dental implant fx6008swc was removed on (b)(6) 2019 due to failure to osseointegrate 16 days after implantation.The patient has history of tobacco use, hypertension, and diabetes.The doctor noted local infection during explantation.The patient has recovered without complications.
 
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Brand Name
SUPERLINE
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
DENTIUMUSA
6761 katella ave
cypress CA 90630
MDR Report Key8809450
Report Number3005503242-2019-00112
Device Sequence Number320637
Product Code DZE
UDI-Device IdentifierD755FX6008SWC0
UDI-PublicD755FX6008SWC0
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 Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 07/19/2019
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 Date06/13/2026
Device Model NumberFX6008SWC
Device Catalogue NumberFX6008SWC
Device Lot NumberF12PB123S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/17/2019
Initial Report FDA Received Date07/19/2019
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 Age53 YR
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