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

Catalog Number 811037C

Device Problems Unintended Ejection (1234); Detachment of Device or Device Component (2907)

Patient Problems Laceration(s) (1946); Pain (1994)

Event Date 02/15/2021

Event Type  Injury  

Manufacturer Narrative

Device was not returned.Patient is fine.

Event Description

On (b)(6) 2021 doctor was prepping tooth #11 for a crown.During the final occlusal reduction he was using a new solo barrel 811037c and the diamond flew out of the highspeed handpiece and cut the upper left cheek of the patient.2x2 cotton was applied to the patient's face.

• Brand Name: SOLO DIAMOND
• Type of Device: DENTAL DIAMOND
• Manufacturer (Section D): PREMIER DENTAL PRODUCTS COMPANY; 1710 romano drive; plymouth meeting PA 19462
• Manufacturer (Section G): ABRASIVE TECHNOLOGY, INC; 8400 green meadows drive n; lewis center OH 43035
• Manufacturer Contact: jessica huang ; 1710 romano drive; plymouth meeting, PA 19462 ; 6102396069
• MDR Report Key: 11561107
• MDR Text Key: 241979460
• Report Number: 2511556-2021-00002
• 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: company representative,health
• Reporter Occupation: Dentist
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 03/17/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2024
• Device Catalogue Number: 811037C
• Device Lot Number: 30EI
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2019
• 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): Death; Other