MAUDE Adverse Event Report: PREMIER DENTAL PRODUCTS COMPANY PRIVA ROTARY INSTRUMENTS¿ DIAMOND BURS; PRIVA DIAMOND BUR

Catalog Number	P245009M
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The priva diamonds bent just below the abrasive length of the diamond bur while using on a patient.The patient is fine.

• Brand Name: PRIVA ROTARY INSTRUMENTS¿ DIAMOND BURS
• Common Device Name: PRIVA DIAMOND BUR
• Manufacturer (Section D): PREMIER DENTAL PRODUCTS COMPANY; 1710 romano drive; plymouth meeting PA 19462
• Manufacturer (Section G): ABRASIVE TECHNOLOGY LLC; 8400 green meadows dr; lewis center OH 43035
• Manufacturer Contact: jessica huang ; 1710 romano drive; plymouth meeting, PA 19462 ; 6102396069
• MDR Report Key: 25187455
• Report Number: 2511556-2026-00004
• Device Sequence Number: 10702264
• Product Code: DZP
• UDI-Device Identifier: 00348783013436
• UDI-Public: 00348783013436
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: P245009M
• Device Lot Number: 1264402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown