MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH CEREC AC OMNICAM / CONNECT; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Model Number 6371830

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 11/06/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation has shown that the device, omnicam, was working in accordance to the specifications and no malfunction has occurred.The market analysis has shown that there were no similar incidents reported to sirona, while about 20,000 devices are placed in the market, running about 10,000,000 acquisitions per year.

Event Description

Epileptic seizure during the acquisition with the cerec ac omnicam.During a user training within the dental office of d."client," a trainee (dental assistant) has used the omnicam device to achieve an acquisition of the patient's (in this case a further trainee) teeth.During the examination after approximately 30 seconds, the trainee broke down with an obviously visible epileptic seizure.A medical doctor in the same office could quickly provide first aid and afterwards the dental assistant was admitted to a clinic.In the meantime, she recovered and left the clinic.The trainee did not know that she suffers from epilepsy.

• Brand Name: CEREC AC OMNICAM / CONNECT
• Type of Device: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• Manufacturer Contact: michael justen ; fabrikstrasse 31; bensheim, D-646-25 ; GM D-64625
• MDR Report Key: 7086206
• MDR Text Key: 93820798
• Report Number: 9614977-2017-00001
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6371830
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR