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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 FX5010SWC
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); Post Operative Wound Infection (2446); Inadequate Osseointegration (2646)
Date of Event 07/14/2021
Type of Reportable Event Serious Injury
Event or Problem Description
The doctor reported that the implant was removed due to loss of osseointegration approximately 8 years after initial implant placement.Bone quality around the area was type ii, and oral hygiene around the implant was moderate.During the surgery bone resorption and peri-implantitis was reported.The 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 Key12305125
Report Number3005503242-2021-00105
Device Sequence Number3839730
Product Code DZE
UDI-Device IdentifierD755FX5010SWC0
UDI-PublicD755FX5010SWC0
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 Year2021
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) 08/10/2021
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 Health Professional
Device Expiration Date04/01/2020
Device Model NumberFX5010SWC
Device Catalogue NumberFX5010SWC
Device Lot NumberC20VA416S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/02/2021
Initial Report FDA Received Date08/10/2021
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;
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