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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LINVATEC CORPORATION D/B/A CONMED LINVATEC OVAL BUR BUR, SURGICAL, GENERAL & PLASTIC SURGERY

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LINVATEC CORPORATION D/B/A CONMED LINVATEC OVAL BUR BUR, SURGICAL, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 5091-236
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Medium oval bur manufactured by conmed broke into 2 pieces during oral surgery. All pieces were retrieved.
 
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Brand NameOVAL BUR
Type of DeviceBUR, SURGICAL, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
LINVATEC CORPORATION D/B/A CONMED LINVATEC
11311 concept blvd.
largo, FL 33773
MDR Report Key5433543
MDR Text Key38100866
Report Number5433543
Device Sequence Number1
Product Code NLP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/31/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue Number5091-236
Device Lot Number671288
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/31/2015
Event Location Hospital
Date Report to Manufacturer12/31/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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