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

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.

• Brand Name: OVAL BUR
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): LINVATEC CORPORATION D/B/A CONMED LINVATEC; 11311 concept blvd.; largo, FL 33773
• MDR Report Key: 5433543
• MDR Text Key: 38100866
• Report Number: 5433543
• Device Sequence Number: 1
• Product Code: NLP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 5091-236
• Device Lot Number: 671288
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/31/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 102