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

Catalog Number 791430

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 device was returned for evaluation.Evaluation of 1 device found normal chuck wear and the turbines needed to be replaced.The devices were repaired and returned to the customers.

Event Description

This report summarizes 2 malfunction events.This report summarizes 1 malfunction event where a midwest phoenix handpiece would not hold dental burs.There were no injuries in any of the events.

• Brand Name: MIDWEST PHOENIX
• 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: 10767370
• MDR Text Key: 214143696
• Report Number: 9614977-2020-00033
• 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: 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: 791430
• Type of Device Usage: N
• Patient Sequence Number: 1