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

Model Number SOLO 2137C

Device Problems Unintended Ejection (1234); Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)

Patient Problem Tooth Fracture (2428)

Event Date 11/18/2021

Event Type  Injury  

Event Description

While prepping a #2 build-up, dentist switched to switched to the solo bur for occlusal reduction.Bur spun-out and bent at the shaft striking the tooth and breaking it.

• 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, LLC; 8400 green meadows drive north; lewis center OH 43035
• Manufacturer Contact: jessica huang ; 1710 romano drive; plymouth meeting, PA 19462 ; 6102396000
• MDR Report Key: 12913555
• MDR Text Key: 281581489
• Report Number: 2511556-2021-00005
• 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: 12/01/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: SOLO 2137C
• Device Catalogue Number: 811037C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Male