MAUDE Adverse Event Report: DENTIUM USA SUPERLINE II; DENTAL IMPLANT

Model Number	FXS3610C
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please see attached summary memo.
Event or Problem Description
The fixture with attached cover screw was returned.Sla surface treatment was confirmed.The visual examination was acceptable.The doctor reported on form f1060, rev 8 that the returned fixture was fxs3608c lot c29kc232s.The related sales order # (b)(4) confirmed that fxs3610c lot c29kc232s was ordered and shipped.This was confirmed with (b)(6) from (b)(6) office by dentium staff mk.The doctor reported the implant was removed due to osseointegration failure within 1 year, approximately 12 days after implant placement.The oral hygiene around implant was good, and bone quality was type i.No significant finding was found during the removal surgery.Bone augmentation material was not used in implant placement surgery.The patient will need another surgical intervention.

• Brand Name: SUPERLINE II
• 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: 20623338
• Report Number: 3005503242-2024-00129
• Device Sequence Number: 7353458
• Product Code: DZE
• UDI-Device Identifier: D755FXS3610C0
• UDI-Public: D755FXS3610C0
• 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: 2024
• 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): 11/06/2024

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: FXS3610C
• Device Lot Number: C29KC232S
• 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: 03/31/2023
• 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: 36 YR
• Patient Sex: Male