MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH T1 LINE C 200 L; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 3328452

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Event Description

This report summarizes 1 malfunction event where a t1 line handpiece overheated.The patient experienced a minor burn, no intervention was required.

Manufacturer Narrative

1 of 1 device was returned for evaluation.The evaluation of 1 device has shown that the device was manipulated and re-assembled with a spare-part (head drive inclusive bearing and chuck system), which was not manufactured by sirona dental systems gmbh.This event is being submitted as part of vmsr.Only one event was received for this device during this quarter.

• Brand Name: T1 LINE C 200 L
• 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: hannah seevaratnam ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 15634981
• MDR Text Key: 306538458
• Report Number: 9614977-2022-00063
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K972436
• 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

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 3328452
• Patient Sequence Number: 1