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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 FX3412MLC
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event 03/01/2021
Type of Reportable Event Serious Injury
Event or Problem Description
The doctor reported that the implant was removed due to osseointegration failure approximately 3 months after initial implant placement.Bone quality around the area was type 2, and oral hygiene around the implant was moderate.During the surgery, local infection, bone resorption, and peri-implantitis were observed.Patient has recovered since.
 
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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 Key11632144
Report Number3005503242-2021-00044
Device Sequence Number14252217
Product Code DZE
UDI-Device IdentifierD755FX3412MLC0
UDI-PublicD755FX3412MLC0
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K041368
Number of Events Summarized1
Summary Report (Y/N)Y
Device Implanted Year2020
Device Explanted Year2021
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) 04/07/2021
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 Date12/13/2024
Device Model NumberFX3412MLC
Device Catalogue NumberFX3412MLC
Device Lot NumberL08RA953S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/23/2021
Initial Report FDA Received Date04/07/2021
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 Age56 YR
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