MAUDE Adverse Event Report: LARES RESEARCH PERFECT FINISH; CONTRA ANGLE PUSH BUTTON LATCH HEAD

Model Number	1:1 CONTRA ANGLE
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned to lares research.A report update will be prepared at that time.
Event or Problem Description
Dr.Sent email and indicated he was working on a pediatric patient when the head cap came off his low-speed contra angle.Patient was referred to have a chest x-ray to rule out ingestion or aspiration of parts.From device photo sent by dr.All parts are accounted for.
Additional Manufacturer Narrative
The device is expected to be returned to lares research.A report update will be prepared at that time.The device was returned to lares research for evaluation.There were no manufacturer defects noted in the evaluation.All components functioned as intended when re-assembled.It was not clear what caused the head cap to come off during operation.
Event or Problem Description
Dr.Sent email and indicated he was working on a pediatric patient when the head cap came off his low-speed contra angle.Patient was referred to have a chest x-ray to rule out ingestion or aspiration of parts.From device photo sent by dr.All parts are accounted for.

• Brand Name: PERFECT FINISH
• Common Device Name: CONTRA ANGLE PUSH BUTTON LATCH HEAD
• 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: 23865688
• Report Number: 2916440-2025-00010
• Device Sequence Number: 17475565
• Product Code: EGS
• UDI-Device Identifier: D950116310
• UDI-Public: D950116310
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K073652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1:1 CONTRA ANGLE
• Device Catalogue Number: 11631
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2025
• 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
• Patient Sex: Unknown