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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 FX6010SWC
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes Failure of Implant (1924); Inadequate Osseointegration (2646); Patient Problem/Medical Problem (2688)
Date of Event 09/16/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The doctor reported that implant was removed due to osseointegration failure approximately a month since the date of surgery.Bone type observed in the area was type 2, and oral hygiene around the site of surgery was moderate.During the surgery, peri-implantitis was observed.
 
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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 Key10738273
Report Number3005503242-2020-00167
Device Sequence Number3318402
Product Code DZE
UDI-Device IdentifierD755FX6010SWC0
UDI-PublicD755FX6010SWC0
Combination Product (Y/N)Y
Initial Reporter StateNY
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) 10/26/2020
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 NumberFX6010SWC
Device Catalogue NumberFX6010SWC
Device Lot NumberD09OB519S
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/12/2020
Initial Report FDA Received Date10/26/2020
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 Age54 YR
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