MAUDE Adverse Event Report: LARES RESEARCH LARES RESEARCH; HIGH-SPEED DENTAL HANDPIECE

Model Number	757 PROSTYLE SF
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Integrity Problem (2978)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.Had a bur bend while operating on patient.The tooth was cracked as a result of the bent bur.The tooth was saved and a crown was installed.
Additional Manufacturer Narrative
This follow-up report was prepared based on the returned device evaluation.The handpiece was used well beyond its useful life, and had non-manufacturer authorized parts.The chucking mechanism and the bur that was installed in the returned device were severely worn which most likely caused the bur to become unstable and bend.
Event or Problem Description
Dr.Had a bur bend while operating on patient.The tooth was cracked as a result of the bent bur.The tooth was saved and a crown was installed.

• Brand Name: LARES RESEARCH
• Common Device Name: HIGH-SPEED DENTAL HANDPIECE
• Manufacturer (Section D): LARES RESEARCH; 295 lockheed avenue; chico CA 95973
• Manufacturer (Section G): LARES RESEARCH; 295 lockheed avenue; chico CA 95973
• Manufacturer Contact: bruce holderbein ; 295 lockheed avenue; chico, CA 95973 ; 5303451767
• MDR Report Key: 22565082
• Report Number: 2916440-2025-00004
• Device Sequence Number: 9237402
• Product Code: EFB
• UDI-Device Identifier: D950131402220
• UDI-Public: D950131402220
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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: 757 PROSTYLE SF
• Device Catalogue Number: 13140-222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown