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

Model Number 2027

Device Problems Connection Problem (2900); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

Per complaint# (b)(4), complainant (dentist) reports a device malfunction for vendor part, nouvag implant machine md11, in which using handpiece for the first time.Drills will not latch onto the handpiece.No patient impact was reported and no narrative suggests there was any harm to patient.

• 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: 7368277
• MDR Text Key: 103521682
• Report Number: 3001617766-2018-00050
• 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: 02/27/2018,03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• 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: 1168E1704R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• 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: 02/27/2018
• Type of Device Usage: N
• Patient Sequence Number: 1