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

Model Number MAXIMA ELITE ELECTRIC CA

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 04/05/2022

Event Type  Injury  

Event Description

On 04/08/2022, hhc was notified that a patient had was burnt from this item.On 04/12/2022, hhc received additional information which included, the type of burn experienced was that their lower lip burnt when hand piece overheated as prepping a crown when had rubber dental dam on patient.The patient did not require any medical attention.The burn was experienced on the lower lip.The patient is fine with no scarring.The procedure was a crown prep with rubber dam in place.The part of the handpiece that caused the burn was the handpiece about 1/3 way back from bur tip.

• Brand Name: MAXIMA ELITE
• Type of Device: HANDPIECE
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim D-646 25; GM D-64625
• MDR Report Key: 14288555
• MDR Text Key: 290799846
• Report Number: 3007007357-2022-00006
• 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: 05/04/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2022
• Distributor Facility Aware Date: 04/08/2022
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/06/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Male