MAUDE Adverse Event Report: KAVO DENTAL GMBH ELEMENTS 8:1 HANDPIECE

Catalog Number 065-1655

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 06/28/2017

Event Type  Injury  

Event Description

An alleged complaint was reported that a file broke in the patient's canal resulting in the doctor extracting the patient's tooth.

Manufacturer Narrative

This update is to state that the device in the alleged incident was evaluated by the manufacturer through a visual and functional test.The tests yielded the device meeting all specifications.In addition, this update is also to update the lot serial number.The serial number on this follow up report is the correct number.

Event Description

An alleged complaint was reported that a file broke in the patient's canal resulting in the doctor extracting the patient's tooth.Patient information: age, sex, weight, ethnicity, and race were not provided from the complainant.

• Brand Name: ELEMENTS 8:1 HANDPIECE
• Type of Device: HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarking 39; biberach, 88400 ; GM 88400
• MDR Report Key: 6752319
• MDR Text Key: 81359779
• Report Number: 2024312-2017-00001
• Device Sequence Number: 1
• Product Code: DZN
• 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,Followup
• Report Date: 06/28/2017

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: Dentist
• Device Catalogue Number: 065-1655
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/28/2017
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other