MAUDE Adverse Event Report: DENTIUM USA SUPERLINE; DENTAL IMPLANT

Model Number	FX5008SWC
Medical Device Problem Codes	Material Fragmentation (1261); Use of Device Problem (1670)
Health Effect - Clinical Codes	Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Date of Event	12/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reported that the implant was removed due to abutment damage approximately 2 years and 6 months after initial implant placement.Bone quality around the area was type 2, and oral hygiene around the implant was good.During the surgery, no significant findings were observed.Patient has since recovered.
Event or Problem Description
The doctor reported that the implant was removed due to abutment damage approximately 2 years and 6 months after initial implant placement.Bone quality around the area was type 2, and oral hygiene around the implant was good.During the surgery, no significant findings were observed.Patient has since recovered.
Additional Manufacturer Narrative
Fx5008swc-lot #a04qb019s manufacture date and expiration date was corrected.

• Brand Name: SUPERLINE
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): DENTIUM USA; 6761 katella ave; cypress CA 90630
• MDR Report Key: 11330548
• Report Number: 3005503242-2020-00247
• Device Sequence Number: 1151098
• Product Code: DZE
• UDI-Device Identifier: D755FX5008SWC0
• UDI-Public: D755FX5008SWC0
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160965
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2021

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 Date: 01/10/2025
• Device Model Number: FX5008SWC
• Device Catalogue Number: FX5008SWC
• Device Lot Number: A04QB091S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 02/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR