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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTIUM USA SUPERLINE; IMPLANT, ENDOSSEOUS, ROOT-FORM
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DENTIUM USA SUPERLINE; IMPLANT, ENDOSSEOUS, ROOT-FORM Back to Search Results
Model Number FX7008SWC
Medical Device Problem Codes Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event 12/26/2016
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant, fx7008swc in tooth location 9 was removed on (b)(6) 2016 due to loss of osseointegration 2 years and 5 months after implantation.The doctor indicated that the patient's poor oral hygiene,pain and infection caused the implant removal.The patient had medical history of diabetic.The patient has recovered without any complications.
 
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Brand Name
SUPERLINE
Common Device Name
IMPLANT, ENDOSSEOUS, ROOT-FORM
Manufacturer (Section D)
DENTIUM USA
6761 katella avenue
cypress CA 90630
MDR Report Key6364724
Report Number3005503242-2017-00006
Device Sequence Number975167
Product Code DZE
UDI-Device IdentifierD755FX7008SWC0
UDI-PublicD755FX7008SWC0
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K160965
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2016
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 02/28/2017
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 Date11/30/2019
Device Model NumberFX7008SWC
Device Lot NumberI09WA390S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/01/2017
Initial Report FDA Received Date02/28/2017
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 Age68 YR
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