MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MW ONCE FTB 368 023 SF; BUR, DENTAL

Catalog Number 1368023SF

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

0 of 1 devices were returned for evaluation.Multiple unsuccessful attempts were made to obtain the device for evaluation.

Event Description

This report summarizes 1 malfunction events.This report summarizes one malfunction event where a midwest once diamond bur walked out of a handpiece.There was no injury in the event.

• Brand Name: MW ONCE FTB 368 023 SF
• Type of Device: BUR, DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 9262992
• MDR Text Key: 184699994
• Report Number: 9614977-2019-00153
• 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: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1368023SF
• Type of Device Usage: N
• Patient Sequence Number: 1