MAUDE Adverse Event Report: DENTIUM USA SUPERLINE; DENTAL IMPLANT

Model Number	FX3612SWC
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please see attached summary memo.
Event or Problem Description
The doctor reported the implant was removed due to implant fracture approximately 1 year and 1 month after implant placement.Bone quality around the area was type ii, and oral hygiene around the implant was good.Local infection, bone resorption and peri-implanttitis were observed during removal surgery.Bone augmentation material was not used in implant placement surgery.There was no trauma history to patient related to implant fracture.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 kyung son ; 6761 katella ave; cypress, CA 90630 ; 7142260229
• MDR Report Key: 19076651
• Report Number: 3005503242-2024-00041
• Device Sequence Number: 6424447
• Product Code: DZE
• UDI-Device Identifier: D755FX3612SWC0
• UDI-Public: D755FX3612SWC0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 04/09/2024

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: FX3612SWC
• Device Lot Number: A04LB811S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2022
• 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: 67 YR
• Patient Sex: Female