MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST E PLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 875205

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

Additional serial number included in this report: (b)(4).0 of 6 devices have been returned for evaluation.Evaluation results will be submitted as they become available.

Event Description

This report summarizes 6 malfunction events.This report summarizes 6 malfunction events where a midwest e plus handpiece would not hold dental burs.There were no injuries in any of the events.

• Brand Name: MIDWEST E PLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT
• 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: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 10767381
• MDR Text Key: 220248562
• Report Number: 9614977-2020-00038
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K965238
• Number of Events Reported: 6
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 875205
• Type of Device Usage: N
• Patient Sequence Number: 1