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

Model Number 2137C

Device Problem Material Twisted/Bent (2981)

Patient Problem Tooth Fracture (2428)

Event Date 03/16/2023

Event Type  Injury  

Event Description

Dentist inserted premier's solo diamond bur (sku: 811037c) into a yabangbang handpiece and tested outside of the patient's mouth without issue.The dentist proceeded to cu a crown prep on tooth #30.The burr bent immediately and cut into adjacent took #29 and fractured it.Patient is fine now but will need a root canal and crown.

Manufacturer Narrative

Dentist used a high-speed handpiece which operated at a higher rpm which was contraindicated for the use of premier's solo diamond burr.

• 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): PREMIER MEDICAL MANUFACTURING; 10090 sandmeyer ln; philadelphia PA 19116
• Manufacturer Contact: jessica huang ; 1710 romano drive; plymouth meeting, PA 19462 ; 2156769090
• MDR Report Key: 16724202
• MDR Text Key: 313128386
• Report Number: 2511556-2023-00001
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/11/2023

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 Model Number: 2137C
• Device Catalogue Number: 811037C
• Device Lot Number: MO112448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• 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