MAUDE Adverse Event Report: Paltop Advanced Dental Solutions Inc. ADVNC; Advanced Implant SP 3.75x11.5

Model Number	20-70002
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2026
Type of Reportable Event	Serious Injury

• Brand Name: ADVNC
• Common Device Name: Advanced Implant SP 3.75x11.5
• Manufacturer (Section D): Paltop Advanced Dental Solutions Inc.; 13645 alton pkwy ste a; irvine CA 92618
• Manufacturer (Section G): Paltop Advanced Dental Solutions Inc.; 13645 alton pkwy ste a; irvine CA 92618
• Manufacturer Contact: brian lanza ; 13645 alton pkwy ste a; irvine, CA 92618 ; +1(774)210-0390
• MDR Report Key: 50930985
• Report Number: 3009161350-2026-02343
• Device Sequence Number: 13451644
• Product Code: DZE
• UDI-Device Identifier: 07290108690019
• UDI-Public: (01)07290108690019(17)290310(10)WO-028227
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 20-70002
• Device Catalogue Number: 20-70002
• Device Lot Number: WO-028227
• Date Returned to Manufacturer: 09/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2023
• 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: 58 YR
• Patient Sex: Female