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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 FX3608SWC
Medical Device Problem Codes Use of Device Problem (1670); Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes Failure of Implant (1924); Inadequate Osseointegration (2646); Patient Problem/Medical Problem (2688)
Date of Event 10/20/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The doctor reported that implant was removed due to loss of osseointegration, approximately 2 years after the implant placement date.Oral hygiene around the implant site was good.Bone quality at surgical site was type 1.During the surgery, periodontal disease was observed.Patient will later require another surgical intervention.
 
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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 Key10814325
Report Number3005503242-2020-00187
Device Sequence Number4124104
Product Code DZE
UDI-Device IdentifierD755FX3608SWC0
UDI-PublicD755FX3608SWC0
Combination Product (Y/N)Y
Initial Reporter StateOH
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) 11/09/2020
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 Date10/17/2025
Device Model NumberFX3608SWC
Device Catalogue NumberFX3608SWC
Device Lot NumberJ17QB221S
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/28/2020
Initial Report FDA Received Date11/09/2020
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 Age53 YR
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