MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST OPERATIVE CARBIDE BUR, CYLINDER FLAT END CROSSCUT; BUR, DENTAL

Catalog Number 386427

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

One device was returned for evaluation.The device was evaluated and found to be within specification.Also, the handpieces used with this device were evaluated and also found to be within specification.

Event Description

This report summarizes 1 malfunction events.It was reported that a midwest carbide dental bur walked out of a handpiece during use; no injury resulted.

• Brand Name: MIDWEST OPERATIVE CARBIDE BUR, CYLINDER FLAT END CROSSCUT
• Type of Device: BUR, DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• Manufacturer (Section G): BEAVERS DENTAL, DIV. SYBRON CANADA LP; 55 laurier; morrisburg, K0C1X 0; CA K0C1X0
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 8847858
• MDR Text Key: 184716814
• Report Number: 9614977-2019-00104
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 386427
• Type of Device Usage: N
• Patient Sequence Number: 1