MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH T2 LINE A 200 L; HANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL

Catalog Number 6376177

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

Event Description

This report summarizes 1 malfunction event where a t2 line handpiece overheated.No injury resulted in the event.

Manufacturer Narrative

1 of 1 device was returned for evaluation.Evaluation of one device found excessive wear due to a lack of proper maintenance and lubrication.The device did not heat up during evaluation.The device was repaired and returned to the customer.This event is being submitted as part of vmsr.Only one event was received for this device during this quarter.

• Brand Name: T2 LINE A 200 L
• 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: hannah seevaratnam ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 15635012
• MDR Text Key: 307011486
• Report Number: 9614977-2022-00064
• 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): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2022

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 Catalogue Number: 6376177
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2022
• Patient Sequence Number: 1