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

Catalog Number 792331

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 devices were returned for evaluation.Evaluation of 1 device found chuck wear and lack of maintenance.The devices were cleaned of debris and the turbines were replaced.The devices were repaired and returned to the customers.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 stylus plus handpiece would not hold burs.No injury resulted.

• Brand Name: MIDWEST STYLUS PLUS
• 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.; york, PA 17401 ; 7178494593
• MDR Report Key: 16789752
• MDR Text Key: 313764869
• Report Number: 9614977-2023-00020
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2023

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 Catalogue Number: 792331
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2023
• Patient Sequence Number: 1