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

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)(6).18 of 19 devices were returned for evaluation.1 device will not be returned for evaluation.Evaluation of two devices found it to be within specification.Evaluation of five devices found excessive wear due to a lack of proper maintenance.Evaluation of one device found excessive wear due to a lack of proper maintenance and lubrication.Evaluation of eight devices found excessive wear due to a lack of proper maintenance and the devices had debris build-up.Evaluation of two devices found excessive wear due to a lack of proper maintenance, lubrication the device had debris build-up.The devices did not heat up during evaluation.The devices were repaired and returned to the customers.

Event Description

This report summarizes 19 malfunction events where a midwest e plus 1:5 high speed contra angle attachment overheated.In 3 events patient experienced minor burn that did not require intervention.In 3 events patients experienced minor burn with the outcome unknown.In no injury resulted in 13 of the events.

• Brand Name: MIDWEST E PLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL PRODUCT CODE EFB
• 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.; york, PA 17401 ; 7178494593
• MDR Report Key: 16781293
• MDR Text Key: 314001945
• Report Number: 9614977-2023-00006
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K972436
• Number of Events Reported: 19
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 875205
• Patient Sequence Number: 1