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U.S. Department of Health and Human Services

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

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NOUVAG AG NOUVAG 5053 IMPLANT HANDPIECE 20:1 Back to Search Results
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.
 
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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 Key7499760
MDR Text Key107791952
Report Number3001617766-2018-00101
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 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 Number5053
Device Catalogue Number5053
Device Lot Number1607H1710R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/17/2018
Event Location Other
Date Report to Manufacturer05/09/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/09/2018
Type of Device Usage N
Patient Sequence Number1
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