InjuryEKW
HENRY SCHEIN
Received Mar 13, 2018 · Event occurred Feb 16, 2018
Report 2411236-2018-00005 · MDR key 7336005
Device
Generic name
Hedstrom Files
Manufacturer
Shenzhen Superline Technology Co., LtdCatalog number
2020126
Lot number
17110103
Product problems
- Break
Patient
33 YR
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
DURING A ROOT CANAL PROCEDURE, A (B)(6) YEAR OLD FEMALE PATIENT HAD THE HEDSTROM FILE BREAK IN THE CANAL. THE PATIENT WAS REFERRED TO SEE A SPECIALIST THE NEXT DAY TO HAVE THE FILE REMOVED. IT IS UNKNOWN IF THE BROKEN FILE WAS ABLE TO BE REMOVED.