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

Catalog Number 875205

Device Problem Overheating of Device (1437)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.

Event Description

It was reported that a midwest e plus 1:5 ca overheated.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

Handpiece got hot during eval.Handpiece failed specs due to bur bearing failure.Replaced head drive.Replaced water hoses.Multiple unsuccessful attempts were made to obtain the patient outcome.

• Brand Name: MIDWEST E PLUS 1:5 HIGHSPEED ATTACHMENT
• Type of Device: HANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• MDR Report Key: 8135417
• MDR Text Key: 129592198
• Report Number: 9614977-2018-00195
• Device Sequence Number: 1
• Product Code: EFA
• Combination Product (y/n): N
• PMA/PMN Number: K965238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

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 Operator: Health Professional
• Device Catalogue Number: 875205
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 11/28/2018
• Supplement Dates FDA Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1