MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST TRADITION PRO HANDPIECE; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 790345

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

1 of 1 device's were returned for evaluation.Evaluation of 1 device found normal chuck wear and the turbine needed to be replaced.The device was repaired and returned to the customer.This event is being submitted as part of vmsr.Only one event was received for this device during this quarter.

Event Description

This report summarizes 1 malfunction event where a midwest tradition pro handpiece would not hold burs.No injury resulted in the event.

• Brand Name: MIDWEST TRADITION PRO HANDPIECE
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 12257070
• MDR Text Key: 264472494
• Report Number: 9614977-2021-00041
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K131319
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 790345
• Type of Device Usage: N
• Patient Sequence Number: 1