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

Catalog Number 720485

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 was returned for evaluation.Evaluation of 1 device found excessive wear due to a lack of proper maintenance.The device did heat up during evaluation.The device was repaired and returned to the customer.

Event Description

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

Manufacturer Narrative

The information in field d3 was inadvertently missed during the initial submission.This submission is to correct the report to include this additional information.

• Brand Name: MIDWEST TRADITION 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
• MDR Report Key: 11758359
• MDR Text Key: 251735638
• Report Number: 9614977-2021-00006
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K963050
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

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?: No
• Device Operator: No Information
• Device Catalogue Number: 720485
• Device Lot Number: A7934887
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2021
• Patient Sequence Number: 1