MAUDE Adverse Event Report: PALTOP ADVANCED DENTAL SOLUTIONS INC. PCA; CONICAL ACTIVE IMPLANT 4.2X8

Model Number	22-70006
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Failed to osseointegrate.
Additional Manufacturer Narrative
Failure to osseointegrate is a well-known and inherent risk of dental implants and is documented in the literature across implant systems1, 2 (see e.G., keller, 1995; bornstein, 2008,).Paltop dental solutions inc.Provides ifu with all implants.Failure to osseointegrate, and loss of osseointegration (implant mobility) is identified as an adverse reaction and identified in the list of warnings in all end-osseous dental implant labelling.The specific cause for a particular complaint is often not readily identified as there are various factors that contribute to the risk of implant failure.These include systemic medical condition (uncontrolled diabetes mellitus, aids, osteoporosis), poor bone quality and quantity of bone in which the implant is implanted, medications (corticosteroids, bisphosphonates), harmful habits to healing (smoking), secondary infection and/or surgical trauma, unexperienced clinician, improper surgical technique, or mobility of the implant leads to its removal or replacement, hence dental implant failure.In addition, a rate of implant failure that does not affect the products' risk assessment does not require investigation as it is a well-known failure mode which has been adequately studied in the past.

• 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 ; 7742100390
• MDR Report Key: 25077944
• Report Number: 3009161350-2026-00818
• Device Sequence Number: 16123746
• Product Code: DZE
• UDI-Device Identifier: 07290108692181
• UDI-Public: (01)07290108692181(17)280622(10)WO-025964
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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: Distributor
• Initial Reporter Occupation: 505
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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-025964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2023
• 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