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

Catalog Number 863012C

Device Problems Break (1069); Unintended Ejection (1234)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/16/2023

Event Type  Injury  

Event Description

The diamond bur ejected in the patients mouth and was swallowed by the patient.

• 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 north; lewis center, OH 43035
• Manufacturer Contact: jessica huang ; 1710 romano drive; plymouth meeting 19462 ; 6102396000
• MDR Report Key: 18544785
• MDR Text Key: 333265018
• Report Number: 2511556-2023-00008
• 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: Other
• Type of Report: Initial
• Report Date: 01/17/2024

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: 863012C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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