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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 FX4308MLC
Medical Device Problem Codes Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes Pain (1994); Inadequate Osseointegration (2646)
Date of Event 08/16/2017
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant fx4010swc was removed on (b)(6) 2017 due to loss of integration four years and two months after implantation.The doctor indicated that bone resorption, peri-implantitis, and patient pain caused the implant removal.The patient has history of diabetes and hypertension and has been recovered without complications.
 
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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 Key6897552
Report Number3005503242-2017-00074
Device Sequence Number873454
Product Code DZE
UDI-Device IdentifierD755FX4308MLC0
UDI-PublicD755FX4308MLC0
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 Year2013
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 09/27/2017
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 Date03/31/2022
Device Model NumberFX4308MLC
Device Catalogue NumberFX4308MLC
Device Lot NumberB21TA540S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/28/2017
Initial Report FDA Received Date09/27/2017
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 Age86 YR
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