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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 FX3808MLC
Medical Device Problem Codes Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 03/21/2016
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant, fx3808mlc in tooth location #18 was removed on (b)(6) 2016 due to loss of osseointegration after 4 years 11 months implantation.The doctor indicated that the bone loss was caused that the patient's bite force was overloaded onto the abutment.The condition of the patient is stable, but treatment is ongoing for re-implant.
 
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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 Key5647908
Report Number3005503242-2016-00007
Device Sequence Number10776695
Product Code DZE
UDI-Device IdentifierD755FX3808MLC0
UDI-PublicD755FX3808MLC0
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 Year2011
Device Explanted Year2016
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 05/11/2016
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 Date04/30/2018
Device Model NumberFX3808MLC
Device Lot NumberD22X05J28CR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/15/2016
Initial Report FDA Received Date05/11/2016
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 Age56 YR
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