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

Model Number	FXS4507BC
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	02/08/2024
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 osseointegration failure, 3 months after implant placement.The patient's x-ray was also provided.Bone quality around the area was type iii, and oral hygiene around the implant was good.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.

• 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: 19155367
• Report Number: 3005503242-2024-00049
• Device Sequence Number: 15314304
• Product Code: DZE
• UDI-Device Identifier: D755FXS4507BC0
• UDI-Public: D755FXS4507BC0
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K213599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/22/2024

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: FXS4507BC
• Device Lot Number: C02KC028S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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: 60 YR
• Patient Sex: Male