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

Model Number 5053

Device Problem Device Inoperable (1663)

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 push button on back of handpiece was not working and implant drills get stuck.

• 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: 7499760
• MDR Text Key: 107791952
• Report Number: 3001617766-2018-00101
• 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

• 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: 1607H1710R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2018
• Type of Device Usage: N
• Patient Sequence Number: 1