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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 FX4508SWC
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event 06/24/2020
Type of Reportable Event Serious Injury
Event or Problem Description
Dental implant fx4508swc was removed on (b)(6) 2020 due to osseointegration failure around 6 months after implantation.The patient has history of diabetes, hypertension, and drug abuse.During the surgery, periodontal disease and bone resorption was observed.The patient recovered.
 
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Brand Name
SUPERLINE
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
DENTIUMUSA
6761 katella ave
cypress, ca
MDR Report Key10474928
Report Number3005503242-2020-00132
Device Sequence Number19382964
Product Code DZE
UDI-Device IdentifierD755FX4508SWC0
UDI-PublicD755FX4508SWC0
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K160965
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 08/21/2020
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 No Information
Device Model NumberFX4508SWC
Device Catalogue NumberFX4508SWC
Device Lot NumberE17OB497S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/14/2020
Initial Report FDA Received Date08/31/2020
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 Age69 YR
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