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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOUVAG AG MD11, 40'000RPM MOTOR WITH 20:1 CONTRA ANGLE
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NOUVAG AG MD11, 40'000RPM MOTOR WITH 20:1 CONTRA ANGLE Back to Search Results
Model Number 2027
Device Problem Component Incompatible (1108)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/14/2017
Event Type  malfunction  
Manufacturer Narrative
This instrument will be send to nouvag usa for investigation/repair.
 
Event Description
Per complaint# (b)(4), 1645337-2018-02174, complainant reports a device malfunction for vendor part, nouvag implant machine md11.Doctor was placing a dental implant using kit and md11 for 1st time.The burs they used for placement of 5.2 x 11 wouldn't latch into handpiece.He couldnt drill to depth because bur kept coming out of handpiece.Doctor was able to complete procedure in same visit with a new handpiece.No patient impact was reported, however, if the reported malfunction were to recur, in worst case scenario, there might be a delay in procedure if the doctor did not have another handpiece available.Nouvag has been notified of the issue.
 
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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 Key7404501
MDR Text Key105152997
Report Number3001617766-2018-00055
Device Sequence Number1
Product Code DZI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Dentist
Type of Report Initial
Report Date 04/06/2018
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 Number2027
Device Catalogue Number2027
Device Lot Number8392E1708R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/26/2017
Event Location Other
Date Report to Manufacturer04/06/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/06/2018
Type of Device Usage N
Patient Sequence Number1
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