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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTIUM USA SUPERLINE; DZE
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DENTIUM USA SUPERLINE; DZE Back to Search Results
Model Number FX3614SWC
Medical Device Problem Codes Break (1069); Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes Discomfort (2330); Inadequate Osseointegration (2646)
Date of Event 04/26/2016
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant fx3614swc was removed on (b)(6)2017 due to loss of osseointegration 1 year and 2 months after implantation.Upon removal the implant fractured in the patient's mouth observed at the 9th fixture level thread.The patient has no significant medical history and has bee recovered without complications.
 
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Brand Name
SUPERLINE
Common Device Name
DZE
Manufacturer (Section D)
DENTIUM USA
6761 katella ave
cypress CA 90630
MDR Report Key6795820
Report Number3005503242-2017-00030
Device Sequence Number162568
Product Code DZE
UDI-Device IdentifierD755FX3614SWC0
UDI-PublicD755FX3614SWC0
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
K041368
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2016
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 06/26/2017
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 Date03/31/2020
Device Model NumberFX3614SWC
Device Catalogue NumberFX3614SWC
Device Lot NumberC09VA371S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/17/2017
Initial Report FDA Received Date08/15/2017
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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