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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTIUM USA IMPLANTIUM; DENTAL IMPLANT
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DENTIUM USA IMPLANTIUM; DENTAL IMPLANT Back to Search Results
Model Number FX4310MLC
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event 10/05/2017
Type of Reportable Event Serious Injury
Event or Problem Description
The doctor reported that the implant was removed due to osseointegration failure approximately 10 months after initial implant placement.Bone quality around the area was type 3, and oral hygiene around the implant was moderate.During the surgery, bone resorption was observed.Patient has since recovered.
 
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Brand Name
IMPLANTIUM
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
DENTIUM USA
6761 katella ave
cypress CA 90630
MDR Report Key12026281
Report Number3005503242-2021-00079
Device Sequence Number16487791
Product Code DZE
UDI-Device IdentifierD755FX4310MLC0
UDI-PublicD755FX4310MLC0
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K041368
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
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) 06/18/2021
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 Date03/31/2023
Device Model NumberFX4310MLC
Device Catalogue NumberFX4310MLC
Device Lot NumberC06SA842S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/28/2021
Initial Report FDA Received Date06/18/2021
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 Age47 YR
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