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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 FX5012SWC
Medical Device Problem Codes Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994); Inadequate Osseointegration (2646); Patient Problem/Medical Problem (2688)
Date of Event 11/19/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The doctor reported that implant was removed because patient was experiencing localized pain 2 weeks after implant placement, as well has observation of mobility on the implant.Oral hygiene around the implant site was good.Bone quality at surgical site was type 2.During the surgery, pain and abnormal sensation around implant placement were observed.Patient has since recovered.
 
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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 Key11106144
Report Number3005503242-2020-00230
Device Sequence Number3950119
Product Code DZE
UDI-Device IdentifierD755FX5012SWC0
UDI-PublicD755FX5012SWC0
Combination Product (Y/N)Y
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K160965
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 01/03/2021
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 No Information
Device Model NumberFX5012SWC
Device Catalogue NumberFX5012SWC
Device Lot NumberB03NB420S
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/23/2020
Initial Report FDA Received Date01/03/2021
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 Age78 YR
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