MAUDE Adverse Event Report: KEYSTONE DENTAL, INC. PAI; PAI IMPLANT SP 4.2X10

Model Number	29-70007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant fracture.
Additional Manufacturer Narrative
Implant fracture is a well-documented and long-term complication of dental implants, which is related to high cyclic material fatigue and/or unfavorable loading conditions.Implant fracture risks are adequately captured in risk management documentation and are also captured in the adverse even reaction section of keystone dental's implant information for use, which lists implant fracture as an anticipated outcome.No adverse trends were identified, and the fracture rate is well within the expected rate of occurrence.

• Brand Name: PAI
• Common Device Name: PAI IMPLANT SP 4.2X10
• Manufacturer (Section D): KEYSTONE DENTAL, INC.; 13645 alton pkwy ste a; irvine CA 92618
• Manufacturer (Section G): KEYSTONE DENTAL, INC.; 13645 alton pkwy ste a; irvine CA 92618
• Manufacturer Contact: kathleen labrie ; 13645 alton pkwy ste a; irvine, CA 92618 ; 9784308257
• MDR Report Key: 23062088
• Report Number: 3005990499-2025-71844
• Device Sequence Number: 9680812
• Product Code: DZE
• UDI-Device Identifier: 07290108697261
• UDI-Public: 07290108697261
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 09/16/2025

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: 29-70007
• Device Catalogue Number: 29-70007
• Device Lot Number: WO-016593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male