EXPert Nail 04.031.934SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982094322), received between Apr 16, 2018 and Apr 16, 2018 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HARDWARE REMOVAL OF AN ADOLESCENT NAIL WAS PERFORMED ON (B)(6) 2018. THE PATIENT WAS INITIALLY IMPLANTED WITH ONE (1) ADOLESCENT NAIL AND THREE (3) 4MM LOCKING SCREWS ON (B)(6) 2017. AFTER THE IMPLANT, THE PATIENT STARTED EXPERIENCING PAIN AND BELIEVED THAT THE PAIN WAS CAUSED BY THE NAIL. DUE TO THE PAIN, THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM ON (B)(6) AND THE NAIL WAS REMOVED. THE NAIL WAS NOT REPLACED WITH ANY NEW HARDWARE. THE REMOVAL SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. THE PATIENT WAS REPORTED TO BE FINE AT THE END OF THE PROCEDURE. THIS REPORT IS FOR ONE (1) UNKNOWN Ø8.2MM TI ADOLESCENT LAT ENTRY FEMORAL NAIL-EX/340MM/RT-STER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 7433927 ↗