MAXIMA ELITE BY HENRY SCHEIN 1:5 112-5681

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-20 for MAXIMA ELITE BY HENRY SCHEIN 1:5 112-5681 manufactured by Sirona Dental Systems Gmbh.

Event Text Entries

[139344178] While the dentist was conducting tooth fillings and crown preparations, a handpiece started heating up and burned two patients' cheek as soon as friction was applied to the tooth. One of the patient was prescribed with pain medication and required a follow-up with the dentist. This issue occurred with the use of three (3) handpieces. Both patients received a burn which was localized inside of the cheek where the handpiece made contact with oral tissue. The customer returned all three (3) handpieces associated with this event. However, he did not specify which of the handpiece(s) caused the localized burns. Therefore, we've list all three (3) serial numbers in question. According to the customer, the handpieces sent back caused a lot of heat when the head chuck has pressure placed on it. This was observed by the dentist through applying pressure on the head chuck as well as in the patients' mouth while working on the teeth on the buccal side against the cheek. In other words, the dentist indicated that the handpieces were pressed against the patients' cheeks during dental operations, which attributed to the localized burns. The ifu (instruction for use), included with this product, has two cautionary statements regarding the risk of burning patient's cheek; therefore, this event may be attributed to user error.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3007007357-2019-00002
• MDR Report Key: 8436887
• Date Received: 2019-03-20
• Date of Report: 2019-02-19
• Date of Event: 2019-02-14
• Date Facility Aware: 2019-02-19
• Report Date: 2019-03-20
• Date Reported to FDA: 2019-03-20
• Date Reported to Mfgr: 2019-03-20
• Date Added to Maude: 2019-03-20
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MAXIMA ELITE BY HENRY SCHEIN
• Generic Name: MAXIMA ELITE BY HENRY SCHEIN / HANDPIECE
• Product Code: EFA
• Date Received: 2019-03-20
• Model Number: 1:5
• Catalog Number: 112-5681
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 1 YR
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SIRONA DENTAL SYSTEMS GMBH
• Manufacturer Address: FABRIKSTRASSE 31 BENSHEIM D-64625 GM D-64625

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-03-20