MAUDE Adverse Event Report: NOUVAG AG NOUVAG 5053 IMPLANT HANDPIECE 20:1

Model Number 5053

Device Problem Mechanics Altered (2984)

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

Event Type  malfunction  

Event Description

Per complaint# (b)(4), complainant reports a device malfunction for vendor part, nouvag implant machine md11, in which handpiece latching mechanism does not work.Doctor notes: "in handpiece any kind of burs/drills including ones from implant direct fail to engage & stay engaged when using - drills able to be pulled out without pushing the mechanism on back of handpiece to release drills".Vendor nouvag has been notified of the incident.

• Brand Name: NOUVAG 5053 IMPLANT HANDPIECE 20:1
• Type of Device: IMPLANT HANDPIECE
• Manufacturer (Section D): NOUVAG AG; st gallerstrasse 23-25; goldach, CH-94 03; SZ CH-9403
• MDR Report Key: 7500011
• MDR Text Key: 107791872
• Report Number: 3001617766-2018-00102
• 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: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 5053
• Device Catalogue Number: 5053
• Device Lot Number: 3676H1711R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/17/2018
• Event Location: Other
• Date Report to Manufacturer: 05/09/2018
• Type of Device Usage: N
• Patient Sequence Number: 1