MAUDE Adverse Event Report: PALTOP ADVANCED DENTAL SOLUTIONS INC. ADVN+; ADVANCED + DENTAL IMPLANT Ø4.2MM L6MM

Model Number	20-70005P
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Failed to osseointegrate.

• Brand Name: ADVN+
• Common Device Name: ADVANCED + DENTAL IMPLANT Ø4.2MM L6MM
• 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 ; 7742100390
• MDR Report Key: 25420801
• Report Number: 3009161350-2026-01346
• Device Sequence Number: 6053173
• Product Code: DZE
• UDI-Device Identifier: 07290108695793
• UDI-Public: (01)07290108695793(17)280416(10)WO-025979
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 06/03/2026
• Report Date (Section F): 06/03/2026

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: 20-70005P
• Device Catalogue Number: 20-70005P
• Device Lot Number: WO-025979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2026
• Is the Reporter a Health Professional?: Yes
• Date Report to Manufacturer: 06/03/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2023
• 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 Sex: Female