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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTIUM USA IMPLANTIUM; IMPLANT, ENDOSSEOUS, ROOT-FORM
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DENTIUM USA IMPLANTIUM; IMPLANT, ENDOSSEOUS, ROOT-FORM Back to Search Results
Model Number FX4308MLC
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 06/13/2017
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant fx3812mlc was removed on (b)(6) 2017 due to loss of osseointegration 1 month after implantation.The doctor indicated lack of primary stability was cause for implant removal.The patient has no significant medical history.The patient has been recovered without complications.
 
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Brand Name
IMPLANTIUM
Common Device Name
IMPLANT, ENDOSSEOUS, ROOT-FORM
Manufacturer (Section D)
DENTIUM USA
6761 katella ave
cypress CA 90630
MDR Report Key6722024
Report Number3005503242-2017-00023
Device Sequence Number18887062
Product Code DZE
UDI-Device IdentifierD755FX3812MLC0
UDI-PublicD755FX3812MLC0
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 Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 07/18/2017
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 Dentist
Device Expiration Date12/18/2024
Device Model NumberFX4308MLC
Device Catalogue NumberFX4308MLC
Device Lot NumberL16RB127S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/05/2017
Initial Report FDA Received Date07/18/2017
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 Age48 YR
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