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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUPERLINE; DENTAL IMPLANT
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SUPERLINE; DENTAL IMPLANT Back to Search Results
Model Number FX3608SWC
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event 09/15/2021
Type of Reportable Event Serious Injury
Event or Problem Description
The doctor reported the implant was removed due to osseointegration failure approximately 3 months after initial implant placement.Bone quality around the area was type iii, and oral hygiene around the implant was moderate.Bone resorption around the implant placement area was reported during the implant removal surgery.The patient requires another surgical intervention.
 
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Brand Name
SUPERLINE
Common Device Name
DENTAL IMPLANT
MDR Report Key12628024
Report Number3005503242-2021-00147
Device Sequence Number19156504
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 Year2021
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) 10/13/2021
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 Date07/15/2021
Device Model NumberFX3608SWC
Device Catalogue NumberFX3608SWC
Device Lot NumberG11PB262S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/07/2021
Initial Report FDA Received Date10/13/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured07/16/2018
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age68 YR
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