MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST E PLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT; HANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL

Catalog Number 875205

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional serial numbers included in this report: (b)(4).10 of 56 devices have been returned for evaluation.1 of the 56 devices will not be returned for investigation.Evaluation of the 10 returned device found excessive wear due to a lack of proper maintenance.This devices did not heat up during evaluation.The devices were repaired and returned to the customers.

Event Description

This report summarizes 56 malfunction events.This report summarizes 56 malfunction events where a midwest e plus handpiece overheated.There were 4 events where patients had minor burns, no intervention was required.There were 52 events with no injuries in any of the events.

• Brand Name: MIDWEST E PLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT
• Type of Device: HANDPIECE, BELT AND/OR GEAR DRIVEN, 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: 10767383
• MDR Text Key: 215344187
• Report Number: 9614977-2020-00047
• Device Sequence Number: 1
• Product Code: EFA
• Combination Product (y/n): N
• PMA/PMN Number: K965238
• Number of Events Reported: 56
• 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