NA 447.612Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982224002), received between May 15, 2018 and May 15, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 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.

• InjuryMay 15, 2018Break; Break

  IT WAS REPORTED THAT A CLOSED WEDGE OSTEOTOMY OF PROXIMAL FIRST METATARSAL OF THE RIGHT FOOT WAS PERFORMED ON (B)(6) 2018. DURING THE PROCEDURE, A FIXATION OF BONE FRAGMENTS WAS ACHIEVED WITH 2.0MM 3X8 HOLE Y PLATE-TITANIUM AND 6 CORTEX SCREWS FROM 2.0 MODULAR HANDSET. THE SURGEON REPORTED NO IN-OPERATIVE EVENTS OR MALFUNCTION OF THE IMPLANTS OR INSTRUMENTATION USED. PRIOR TO IMPLANTATION THE STRAIGHT PORTION OF THE PLATE HAD BEEN CUT, AND THE THREE HOLES ON THE END OF THE PLATE WERE REMOVED BEFORE BEING USED ON THE PATIENT. REPORTEDLY, THE PATIENT WAS SEEN IN A POST-OPERATIVE VISIT TWO DAYS LATER AND IMAGES OF THE IMPLANTS SHOWED THE PLATE WAS BROKEN. IT WAS FURTHER EXPLAINED THAT THE JUNCTION BETWEEN THE 3-HOLED PRONGED END OF THE PLATE AND THE STRAIGHT 5-HOLED PORTION WAS BROKEN. ALL SIX IMPLANTED SCREWS WERE INTACT AND IN THE SAME SITE VISUALIZED IN POST-OPERATIVE IMAGING. WHEN ASKED IF ANYTHING HAD OCCURRED BETWEEN THE INITIAL SURGERY AND THE POST-OPERATIVE VISIT, THE PATIENT REPORTED THAT SHE HAD TRIPPED AND FELL ONE HOUR AFTER THE INITIAL SURGERY. THE PATIENT WILL BE REVISED ON (B)(6) 2018, WHEN THE SAME IMPLANT TYPE/SIZE AND NEW SCREWS WILL BE PLACED AND THE TWO BROKEN PLAT

  Patient problems: Failure of Implant

  MAUDE report 7515162 ↗