MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MAXIMA ELITE; HANDPIECE

Model Number MAXIMA ELITE ELECTRIC CA

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 05/26/2022

Event Type  Injury  

Event Description

An assistant at the office, health professional, reports that when prepping buccal of tooth#18 for a filling procedure, the handpiece by the back button that is pressed to engage the bur became hot and burned the patient's cheek.The patient was a 41 year old female patient.The patient was referred to an oral surgeon and was also given antibiotics by the office fearing the area would get infected, not specifying what.The patient also coincidentally also got covid at the same time.Since the date of incident((b)(6) 2022), the husband said that his wife has gotten better.

• Brand Name: MAXIMA ELITE
• Type of Device: HANDPIECE
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim d-64625 ; GM
• MDR Report Key: 15316773
• MDR Text Key: 298860198
• Report Number: 3007007357-2022-00010
• Device Sequence Number: 1
• Product Code: EFA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/01/2022,08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAXIMA ELITE ELECTRIC CA
• Device Catalogue Number: 112-5681
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2022
• Distributor Facility Aware Date: 08/04/2022
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Female