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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 FX3812MLC
Medical Device Problem Codes Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 04/04/2017
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 2 years and 5 months after implantation.The doctor indicated that no findings were observed during the surgery.The patient has medical history of bruxism.The patient need another surgical intervention.
 
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Brand Name
IMPLANTIUM
Common Device Name
IMPLANT, ENDOSSEOUS, ROOT-FORM
Manufacturer (Section D)
DENTIUM USA
6761 katella avenue
cypress CA 90630
MDR Report Key6583519
Report Number3005503242-2017-00013
Device Sequence Number10972257
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 Year2014
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 05/22/2017
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 Date10/31/2020
Device Model NumberFX3812MLC
Device Lot NumberJ25VA539S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/27/2017
Initial Report FDA Received Date05/22/2017
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 Age75 YR
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