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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 FX5008SWC
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event 12/20/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
The dental implant fx5008swc was removed on (b)(6) 2018 due to failure to osseointegrate 23 days after implantation.The patient has no significant medical history.The doctor noted local infection and pain 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 Key8604355
Report Number3005503242-2019-00077
Device Sequence Number2349959
Product Code DZE
UDI-Device IdentifierD755FX5008SWC0
UDI-PublicD755FX5008SWC0
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 Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 05/13/2019
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 Date05/30/2026
Device Model NumberFX5008SWC
Device Catalogue NumberFX5008SWC
Device Lot NumberE30PB309S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/07/2019
Initial Report FDA Received Date05/13/2019
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 Age68 YR
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