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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTIUMUSA IMPLANTIUM; DENTAL IMPLANT
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DENTIUMUSA IMPLANTIUM; DENTAL IMPLANT Back to Search Results
Model Number FX4308MLC
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event 01/15/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant fx4308mlc was removed on (b)(6) 2019 due to failure to osseointegrate 1 month and 10 days after implantation.The patient has no significant medical history.The doctor noted local infection during the surgery.The patient has recovered without complications.
 
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Brand Name
IMPLANTIUM
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
DENTIUMUSA
6761 katella ave
cypress CA 90630
MDR Report Key8310962
Report Number3005503242-2019-00022
Device Sequence Number2126985
Product Code DZE
UDI-Device IdentifierD755FX4308MLC0
UDI-PublicD755FX4308MLC0
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 Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 02/06/2019
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 Date02/28/2023
Device Model NumberFX4308MLC
Device Catalogue NumberFX4308MLC
Device Lot NumberB04SA692S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/31/2019
Initial Report FDA Received Date02/06/2019
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 Age52 YR
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