MAUDE Adverse Event Report: Paltop Advanced Dental Solutions Inc. PCA; Conical Active Implant 4.2x8

Model Number	22-70006
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2026
Type of Reportable Event	Serious Injury

• Brand Name: PCA
• Common Device Name: Conical Active Implant 4.2x8
• 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: 50928794
• Report Number: 3009161350-2026-02340
• Device Sequence Number: 16136033
• Product Code: DZE
• UDI-Device Identifier: 07290108692181
• UDI-Public: (01)07290108692181(17)290627(10)WO-030225
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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: 22-70006
• Device Catalogue Number: 22-70006
• Device Lot Number: WO-030225
• 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: 06/13/2024
• 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: 69 YR
• Patient Sex: Female