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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 FX3608SWC
Medical Device Problem Codes Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646)
Date of Event 04/24/2018
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant fx3608swc was removed on (b)(6) 2018 due to loss of oseointegration 4 years and 4 months after implantation.The doctor noted local infection, peri-implantitis, and pain during surgery.The patient has medical history of hypertension.The patient has recovered without complications.
 
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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 Key7558861
Report Number3005503242-2018-00088
Device Sequence Number19436297
Product Code DZE
UDI-Device IdentifierD755FX3608SWC0
UDI-PublicD755FX3608SWC0
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 Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 05/31/2018
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 Date06/30/2020
Device Model NumberFX3608SWC
Device Catalogue NumberFX3608SWC
Device Lot NumberE23VA449S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/04/2018
Initial Report FDA Received Date05/31/2018
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 Age66 YR
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