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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 FX3414MLC
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event 04/18/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
The dental implant fx3414mlc was removed on (b)(6) 2019 due to failure to osseointegrate 27 days after implantation.The patient has no significant medical history.The doctor noted local infection 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)
DENTIUMUSA
6761 katella ave
cypress CA 90630
MDR Report Key8637118
Report Number3005503242-2019-00081
Device Sequence Number16667010
Product Code DZE
UDI-Device IdentifierD755FX3414MLC0
UDI-PublicD755FX3414MLC0
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K041368
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 05/23/2019
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 Date12/12/2024
Device Model NumberFX3414MLC
Device Catalogue NumberFX3414MLC
Device Lot NumberL08RA567S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/17/2019
Initial Report FDA Received Date05/23/2019
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 Age32 YR
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