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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 FX4810MLC
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event 07/19/2021
Type of Reportable Event Serious Injury
Event or Problem Description
The doctor reported the implant was removed due to osseointegration failure approximately 1 month after initial implant placement.Bone quality around the area was type iii, and oral hygiene around the implant was moderate.Abnormal sensation around the implant placement area was reported during the implant removal surgery.The 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 Key12492906
Report Number3005503242-2021-00143
Device Sequence Number19670471
Product Code DZE
UDI-Device IdentifierD755FX4810MLC0
UDI-PublicD755FX4810MLC0
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 Year2021
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) 09/17/2021
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 Model NumberFX4810MLC
Device Catalogue NumberFX4810MLC
Device Lot NumberH21OB543S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/10/2021
Initial Report FDA Received Date09/17/2021
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 Age76 YR
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