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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 FX6008SWC
Medical Device Problem Codes Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes Pain (1994); Inadequate Osseointegration (2646)
Date of Event 01/26/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
 
Event or Problem Description
Patient developed a loss of integration 2 years 1 month after implantation of the dental implant fx6008swc in tooth location #14.Implant was removed on (b)(6) 2016 due to loss of integration and pain.The patient is recovered without complication and treatment is ongoing.
 
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Brand Name
SUPERLINE
Common Device Name
IMPLANT, ENDOSSEOUS, ROOT-FORM
Manufacturer (Section D)
DENTIUM USA
6761 katella ave.
cypress CA 90630
MDR Report Key5451577
Report Number3005503242-2016-00002
Device Sequence Number375555
Product Code DZE
UDI-Device IdentifierD755FX6008SWC0
UDI-PublicD755FX6008SWC0
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 Year2013
Device Explanted Year2016
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 02/22/2016
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 Date10/30/2020
Device Model NumberFX6008SWC
Device Lot NumberJ09VA370S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/08/2016
Initial Report FDA Received Date02/22/2016
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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