MAUDE Adverse Event Report: PALTOP ADVANCED DENTAL SOLUTIONS INC. PAI; PAI IMPLANT SP 4.2X8

Model Number	29-70006
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Failure to osseointegrate is a well-known and inherent risk of dental implants and is documented in the literature across implant systems 1, 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 labeling.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 conditions (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 that has been adequately studied in the past.
Event or Problem Description
Failed to osseointegrate.

• Brand Name: PAI
• Common Device Name: PAI IMPLANT SP 4.2X8
• Manufacturer (Section D): PALTOP ADVANCED DENTAL SOLUTIONS INC.; 154 middlesex turnpike; burlington MA 01803
• Manufacturer (Section G): PALTOP ADVANCED DENTAL SOLUTIONS INC.; 154 middlesex turnpike; burlington MA 01803
• Manufacturer Contact: zina gurgov ; 154 middlesex turnpike; burlington, MA 01803 ; 7813283490
• MDR Report Key: 20576215
• Report Number: 3009161350-2024-72216
• Device Sequence Number: 8170434
• Product Code: DZE
• UDI-Device Identifier: D76829700060
• UDI-Public: +D76829700060/$$3231028WO009497K
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/31/2024

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 Expiration Date: 10/27/2023
• Device Model Number: 29-70006
• Device Catalogue Number: 29-70006
• Device Lot Number: WO-009497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2018
• 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