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

Catalog Number 792400

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

This report summarizes 13 malfunction events where a midwest stylus plus handpiece would not hold burs.No injury resulted in any of the events.

Manufacturer Narrative

Additional serial numbers included in this report: (b)(4).13 of 13 devices were returned for evaluation.Evaluation of 10 devices found normal chuck wear and the turbines needed to be replaced.The devices were repaired and returned to the customers.Evaluation of 3 devices 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.

• Brand Name: MIDWEST STYLUS PLUS SPM
• 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: 15124533
• MDR Text Key: 304464761
• Report Number: 9614977-2022-00048
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K131319
• Number of Events Reported: 13
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2022

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?: Yes
• Device Catalogue Number: 792400
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2022
• Patient Sequence Number: 1