MalfunctionHTN
NOT REPORTED
Received Jun 10, 2026
Report 3025141-2026-00306 · MDR key 25463742
Device
Product problems
- Implant subsidence
Patient
NA · Unknown
- Pain
Narrative
Description of Event or Problem
IT WAS REPORTED AFTER A CALL WITH THE SURGEON, "WE HAD A CALL WITH THE SURGEON THIS MORNING AND HE MENTIONED HE HAD ONE CASE WHERE THE ROUND BUTTON PULLED THROUGH ALL THE WAY INTO THE THUMB WEB. THE PATIENT HAS NOT REPORTED ANY PAIN AND DOES NOT REQUIRE REVISION." THE SURGEON STATED THE CAUSE OF THIS ISSUE WAS INSUFFICIENT BONE QUALITY AT THE BASE OF THE THUMB METACARPAL.
Additional Manufacturer Narrative
TO DATE, THE DEVICE HAS NOT RETURNED FOR EVALUATION, THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A FOLLOW UP REPORT IF MORE INFORMATION BECOMES AVAILABLE.