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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 FX4508SWC
Medical Device Problem Codes Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes Inadequate Osseointegration (2646); Patient Problem/Medical Problem (2688)
Date of Event 06/20/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The doctor reported the implant was removed due to osseointegration failure 21 months after placement surgery.Bone quality was type ii and oral hygiene at the site of the implant was moderate.During the surgery, bone resorption was observed.The patient has recovered.
 
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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 Key10498287
Report Number3005503242-2020-00146
Device Sequence Number16801229
Product Code DZE
UDI-Device IdentifierD755FX4508SWC0
UDI-PublicD755FX4508SWC0
Combination Product (Y/N)Y
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K160965
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 09/06/2020
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 Expiration Date04/02/2026
Device Model NumberFX4508SWC
Device Catalogue NumberFX4508SWC
Device Lot NumberC28PB285S
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/27/2020
Initial Report FDA Received Date09/06/2020
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 Age60 YR
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