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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 FX4812MLC
Medical Device Problem Codes Use of Device Problem (1670); Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes Failure of Implant (1924); Inadequate Osseointegration (2646); Patient Problem/Medical Problem (2688)
Date of Event 10/21/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The doctor reported that the implant was removed due to osseointegration failure approximately 4 months after the initial implant placement.Bone quality around the area was type i, and oral hygiene around the implant was good.During the surgery it was reported that the implant had not integrated.Patient was reported to have needed another surgical intervention.
 
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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 Key11125025
Report Number3005503242-2020-00234
Device Sequence Number677092
Product Code DZE
UDI-Device IdentifierD755FX4812MLC0
UDI-PublicD755FX4812MLC0
Combination Product (Y/N)Y
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K041368
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
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) 01/06/2021
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 No Information
Device Expiration Date12/31/2022
Device Model NumberFX4812MLC
Device Catalogue NumberFX4812MLC
Device Lot NumberL26TA813S
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/28/2020
Initial Report FDA Received Date01/06/2021
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 Age84 YR
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