MAUDE Adverse Event Report: NOUVAG AG MD11, 40'000RPM MOTOR WITH 20:1 CONTRA ANGLE

Model Number 2027

Device Problems Component Falling (1105); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2017

Event Type  malfunction  

Event Description

Per complaint# (b)(4), complainant (dentist) reports a device malfunction for vendor part, nouvag implant machine md11, in which the latch system on handpiece failed and burr fell out of handpiece into pt's mouth during a clinical dental implant procedure.The procedure was completed in the same visit and no patient impact was reported.

• Brand Name: MD11, 40'000RPM MOTOR WITH 20:1 CONTRA ANGLE
• Type of Device: MD11
• Manufacturer (Section D): NOUVAG AG; st gallerstrasse 23-25; goldach, CH-94 03; SZ CH-9403
• MDR Report Key: 7360571
• MDR Text Key: 103139628
• Report Number: 3001617766-2018-00043
• Device Sequence Number: 1
• Product Code: DZI
• 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: 03/13/2018,03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 2027
• Device Catalogue Number: 2027
• Device Lot Number: 8388E1708R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2017
• Event Location: Other
• Date Report to Manufacturer: 03/13/2018
• Type of Device Usage: N
• Patient Sequence Number: 1