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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTIUMUSA SUPERLINE; DENTAL IMPLANT
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DENTIUMUSA SUPERLINE; DENTAL IMPLANT Back to Search Results
Model Number FX3614SWC
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 08/03/2018
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant fx3614swc was removed on (b)(6) 2018 due to failure to osseointegrate 7 months and 4 days after implantation.The patient required bone augmentation during the surgery.The patient has no significant medical history.The patient has required another surgical intervention to recover.
 
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Brand Name
SUPERLINE
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
DENTIUMUSA
6761 katella ave
cypress CA 90630
MDR Report Key7839783
Report Number3005503242-2018-00143
Device Sequence Number14061814
Product Code DZE
UDI-Device IdentifierD755FX3614SWC0
UDI-PublicD755FX3614SWC0
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
K160965
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 08/31/2018
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 Health Professional
Device Expiration Date09/30/2020
Device Model NumberFX3614SWC
Device Catalogue NumberFX3614SWC
Device Lot NumberI25VA325S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/29/2018
Initial Report FDA Received Date08/31/2018
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 Age37 YR
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