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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 FX4512SWC
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 07/01/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
See summary memo of evaluation.(b)(4).
 
Event or Problem Description
The dental implant fx4512swc was removed on (b)(6) 2020 due to osseointegration failure around 1 month and 18 days after implantation.The patient has no significant medical history.The patient required bone augmentation for the operation.The doctor noted peri-implantitis during explantation.The patient has recovered without complications.
 
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Brand Name
SUPERLINE
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
DENTIUM USA
6761 katella ave
cypress, ca
MDR Report Key10353201
Report Number3005503242-2020-00119
Device Sequence Number2655278
Product Code DZE
UDI-Device IdentifierD755FX4512SWC0
UDI-PublicD755FX4512SWC0
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K160965
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 07/31/2020
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 Health Professional
Device Model NumberFX4512SWC
Device Catalogue NumberFX4512SWC
Device Lot NumberF06OB381S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/28/2020
Initial Report FDA Received Date07/31/2020
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 Age29 YR
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