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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTIUM USA SUPERLINE; DENTAL IMPLANT
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DENTIUM USA SUPERLINE; DENTAL IMPLANT Back to Search Results
Model Number FX6008SWC
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 09/28/2017
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant fx6008swc was removed on (b)(6) 2017 5 months after implantation due to failure to osseointegrate.The patient has no significant medical history and may need another surgical intervention.
 
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Brand Name
SUPERLINE
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
DENTIUM USA
6761 katella ave
cypress CA 90630
MDR Report Key6962545
Report Number3005503242-2017-00101
Device Sequence Number16531410
Product Code DZE
UDI-Device IdentifierD755FX6008SWC0
UDI-PublicD755FX6008SWC0
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K160965
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 10/19/2017
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 Date10/31/2020
Device Model NumberFX6008SWC
Device Catalogue NumberFX6008SWC
Device Lot NumberJ09VA370S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/28/2017
Initial Report FDA Received Date10/19/2017
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 Age58 YR
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