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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 Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes Pain (1994); Inadequate Osseointegration (2646)
Date of Event 02/27/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
[(b)(4)].
 
Event or Problem Description
The dental implant fx4812mlc was removed on (b)(6) 2020 due to failure to osseointegrate 9 months and 12 days after implantation.The patient has no significant medical history.The doctor noted pain during explantation.The patient required another surgical intervention to recover.
 
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Brand Name
IMPLANTIUM
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
DENTIUM USA
6761 katella ave
cypress, ca
MDR Report Key10246619
Report Number3005503242-2020-00086
Device Sequence Number11549177
Product Code DZE
UDI-Device IdentifierD755FX4812MLC0
UDI-PublicD755FX4812MLC0
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K041368
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 07/08/2020
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 Health Professional
Device Expiration Date01/03/2025
Device Model NumberFX4812MLC
Device Catalogue NumberFX4812MLC
Device Lot NumberL27RA922S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/22/2020
Initial Report FDA Received Date07/08/2020
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 Age70 YR
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