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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 FX4012SWC
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Failure of Implant (1924); Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event 09/22/2021
Type of Reportable Event Serious Injury
Event or Problem Description
The doctor reported the implant was removed due to loss of osseointegration approximately 3 years - 8 months after initial implant placement.Bone quality around the area was type ii, and oral hygiene around the implant was moderate.Peri-implantitis 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 Key12627841
Report Number3005503242-2021-00149
Device Sequence Number19156503
Product Code DZE
UDI-Device IdentifierD755FX4012SWC0
UDI-PublicD755FX4012SWC0
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K160965
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
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 Date06/06/2025
Device Model NumberFX4012SWC
Device Catalogue NumberFX4012SWC
Device Lot NumberE31QB169S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/08/2021
Initial Report FDA Received Date10/13/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured06/07/2017
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 Age63 YR
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