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

Model Number 757

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2024

Event Type  malfunction  

Manufacturer Narrative

The customer sent a bur in with the device.The bur used had a shaft length that was not recommended by manufacturer.This may have contributed to the bur coming out.No manufacturing or material defects were noted.

Event Description

Customer reported the bur came out during a procedure.The bur was collected by doctor without injuring the patient.

• Brand Name: PROSTYLE SF
• Type of Device: 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: 19085342
• MDR Text Key: 340700154
• Report Number: 2916440-2024-00004
• Device Sequence Number: 1
• Product Code: EFB
• UDI-Device Identifier: D950136210360
• UDI-Public: D950136210360
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/09/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 757
• Device Catalogue Number: 13621-036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1