K-REAMER M-ACCESS 25MM 030
Received Apr 20, 2026 · Event occurred Dec 7, 2024
Report 8031010-2026-00051 · MDR key 24923401
Device
Generic name
Reamer, Pulp Canal, Endodontic
Manufacturer
Maillefer Instruments Holding SarlCatalog number
A11MA02503012
Lot number
1401120
Product problems
- Break
Patient
NA · Unknown
- Tooth Loss
Narrative
Description of Event or Problem
IN THIS EVENT IT IS REPORTED THAT A K-REAMER M-ACCESS 25MM 030 FILE BROKE DURING USE. THE PATIENT'S TOOTH WAS EXTRACTED.
Additional Manufacturer Narrative
AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS WITH SIMILAR FILES. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.