RTS LESSER
Received Oct 16, 2025 · Event occurred Mar 14, 2024
Report 3011580264-2025-00013 · MDR key 23316699
Device
Generic name
Prosthesis, Toe, Constrained, Polymer
Manufacturer
In2bones UsaModel number
M40 SE020Catalog number
M40 SE020
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Unknown
- Implant Pain
- Implant Pain
Narrative
Description of Event or Problem
PER A RETROSPECTIVE POST-MARKET STUDY, IT WAS DISCOVERED THAT THE DEVICE, M40 SE020, RTS LESSER MTP IMPLANT, SIZE 2, WAS INITIALLY IMPLANTED ON (B)(6) 2024 AND IT WAS REPORTED DUE TO IMPLANT DISLOCATION, A SECONDARY PROCEDURE ON (B)(6) 2025 WAS REQUIRED TO REMOVE THE DEVICE. THE COMPLICATION WAS SOLVED BY REMOVAL OF THE IMPLANT. FURTHER ASSESSMENT INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE TO DATE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF SECONDARY SURGERY FOR REMOVAL OF AN IMPLANT.