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

Catalog Number 811037C

Device Problems Device Damaged by Another Device (2915); Material Twisted/Bent (2981); Unintended Movement (3026)

Patient Problem Tooth Fracture (2428)

Event Date 08/17/2023

Event Type  malfunction  

Event Description

The diamond bur was bent while doctor used the nsk electric handpiece to place a crown into patient's tooth.The patients tooth #13 was fractured.".

• Brand Name: SOLO DIAMOND
• Type of Device: DIAMOND, DENTAL BURR
• Manufacturer (Section D): PREMIER DENTAL PRODUCTS COMPANY; 1710 romano drive; plymouth meeting PA 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 19462 ; 6102396069
• MDR Report Key: 18012060
• MDR Text Key: 326622305
• Report Number: 2511556-2023-00006
• 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: 09/12/2023

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 Operator: Health Professional
• Device Catalogue Number: 811037C
• Device Lot Number: M0117276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• 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; Other