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

Model Number 757

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Tooth Fracture (2428)

Event Type  malfunction  

Event Description

Dr.(b)(6)'s email message (related detail) sent to lares research on (b)(6) 2016: i wanted you to see the picture of the hand piece that malfunctioned.At this point, the patient is seeing a root canal specialist because he has had persistent pain since the incident.I was simply polishing the lingual portion of the filling after the end of the procedure and the hand piece made a popping noise.When i paused and evaluated the hand piece, i noticed the bur completely bent.Second message (related detail) from dr.(b)(6) to lares later that same day: the patient in fact needed a root canal.The fracture extended into the nerve.

• Brand Name: WORKHORSE
• Type of Device: AIR DRIVEN 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: 6419330
• MDR Text Key: 70423864
• Report Number: 2916440-2017-00002
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K905541
• 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: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: 757
• Device Catalogue Number: 10624-021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention