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

Catalog Number 792430

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

Manufacturer Narrative

Additional serial numbers included in this report: 1 of 1 devices were returned for evaluation.Evaluation of one device found excessive wear due to a lack of proper maintenance.A friction problem was identified from pressure on the cap.The device did not heat up during evaluation.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 stylus® plus spk handpiece overheated.No injury resulted.

• Brand Name: MIDWEST STYLUS® PLUS SPK
• 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: dan eagar ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 19164243
• MDR Text Key: 341131644
• Report Number: 9614977-2024-00002
• Device Sequence Number: 1
• Product Code: EFB
• UDI-Device Identifier: E2767924300
• UDI-Public: E2767924300
• 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: 04/19/2024

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: 792430
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2024
• Patient Sequence Number: 1