MalfunctionEMR
PROTAPER FINISHING 25MM/F2(ENDO)
Received Aug 11, 2023
Report MW5123388 · MDR key 17516439
Device
Product problems
- Break
- Product Quality Problem
- Difficult to Remove
- Break
- Product Quality Problem
- Difficult to Remove
Patient
Unknown
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
PROTAPER FINISHING 25MM/F2 BROKEN FILES. PART OF THE FILE WAS NOT REMOVED. (B)(6), (B)(4). PROTAPER FINISHING. 25MM/F2(ENDO). CONSUMABLE. FILES SOLD BY AN UNKNOWN DEALER CALLED "(B)(4)" LOCATED IN FRANCE, AT A VERY LOW PRICE: (B)(4) ?. SUSPICION OF COUNTERFEITING. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).