MAUDE Adverse Event Report: PREMIER DENTAL PRODUCTS COMPANY SOLO DIAMOND; DIAMOND, DENTAL BURR

Catalog Number 811037C

Device Problems Material Twisted/Bent (2981); Unintended Movement (3026)

Patient Problem Tooth Fracture (2428)

Event Date 02/12/2024

Event Type  Injury  

Event Description

The diamond bur was bent while working on a patient's tooth.Patient will need crown and a root canal.

• Brand Name: SOLO DIAMOND
• Type of Device: DIAMOND, DENTAL BURR
• Manufacturer (Section D): PREMIER DENTAL PRODUCTS COMPANY; 1710 romano drive; plymouth meeting, 19462
• Manufacturer (Section G): ABRASIVE TECHNOLOGY, LLC; 8400 green meadows drive n.; lewis center OH 43035
• Manufacturer Contact: jessica huang ; 1710 romano drive; plymouth meeting, PA 19462 ; 6102396069
• MDR Report Key: 18806367
• MDR Text Key: 336521507
• Report Number: 2511556-2024-00001
• Device Sequence Number: 1
• Product Code: DZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/15/2024

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
• Device Catalogue Number: 811037C
• Device Lot Number: M0115551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention