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

Catalog Number 790344

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

Manufacturer Narrative

1 of 1 devices were returned for evaluation.Evaluation of one device found excessive wear due to a lack of proper maintenance and lubrication.The device did not heat up during evaluation.The device was repaired and returned to the customer.The devices had debris build-up.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 handpiece overheated.No injury resulted in the event.

• 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
• 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: 12257009
• MDR Text Key: 264469705
• Report Number: 9614977-2021-00030
• 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: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 790344
• Type of Device Usage: N
• Patient Sequence Number: 1