MAUDE Adverse Event Report: DENTIUM USA SUPERLINE; DENTAL IMPLANT

Model Number	FX4510SWC
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please see summary memo.
Event or Problem Description
The fixture with attached crown was returned.Sla surface treatment was confirmed.Evidence of osseointegration was observed.The visual examination was acceptable.The doctor reported on form f1060, rev 8 that the returned fixture was fsx4510c.The related sales order # (b)(4) confirmed that fx4510swc lot k21ob460s was ordered and shipped.This was confirmed with cassidy ryan from haddon oral's office by dentium staff mk.The doctor reported the implant was removed due to loss of osseointegration approximately 1 year and 1 month after implant placement.The bone quality was type i.The oral hygiene around implant site was moderate.No significant finding was observed during the removal surgery.Bone augmentation material was not used in implant placement surgery.The patient will need another surgical intervention.

• Brand Name: SUPERLINE
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): DENTIUM USA; 6761 katella ave; cypress CA 90630
• Manufacturer (Section G): DENTIUM USA; 6761 katella ave; cypress CA 90630
• Manufacturer Contact: eun son ; 6761 katella ave; cypress, CA 90630 ; 7142260229
• MDR Report Key: 20616309
• Report Number: 3005503242-2024-00127
• Device Sequence Number: 8874507
• Product Code: DZE
• UDI-Device Identifier: D755FX4510SWC0
• UDI-Public: D755FX4510SWC0
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 11/04/2024

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 Model Number: FX4510SWC
• Device Lot Number: K21OB460S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2019
• 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 Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male