MAUDE Adverse Event Report: NOUVAG AG MD11 SURICAL MOTOR SYSTEM

Model Number 2027

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Per complaint# (b)(4), complainant reports a device malfunction for vendor part, nouvag implant machine md11, in which the latch on the handpiece does not latch to the drill.No narrative suggests there was any impact to patient; however there is potential to cause patient harm if the incident were to recur.This is a reportable malfunction.

• Brand Name: MD11 SURICAL MOTOR SYSTEM
• Type of Device: MD11
• Manufacturer (Section D): NOUVAG AG; st gallerstrasse 23-25; goldach, CH-94 03; SZ CH-9403
• MDR Report Key: 7492684
• MDR Text Key: 107573471
• Report Number: 3001617766-2018-00089
• 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: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• 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: 1155E1704R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/09/2018
• Event Location: Other
• Date Report to Manufacturer: 05/07/2018
• Type of Device Usage: N
• Patient Sequence Number: 1