MAUDE Adverse Event Report: DENTIUM USA SUPERLINE; DENTAL IMPLANT

Model Number	FX5010SWC
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reported the implant was removed due to osseointegration failure, 3 months after implant placement.Bone quality around the area was type iv, and oral hygiene around the implant was moderate.Local infection and peri-implantitis were observed during the implant removal surgery.Bone augmentation material was used in implant placement surgery.The patient will need another surgical intervention.The doctor did a socket presentation procedure after the implant came out.
Additional Manufacturer Narrative
Please see attached summary memo.

• 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 kyung son ; 6761 katella ave; cypress, CA 90630 ; 7142260229
• MDR Report Key: 22178408
• Report Number: 3005503242-2025-00079
• Device Sequence Number: 8841471
• Product Code: DZE
• UDI-Device Identifier: D755FX5010SWC0
• UDI-Public: D755FX5010SWC0
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K160965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 06/10/2025

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: FX5010SWC
• Device Catalogue Number: FX5010SWC
• Device Lot Number: H29JC449S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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: 75 YR
• Patient Sex: Male