NA 02.211.263Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982054722), received between Mar 21, 2017 and Mar 21, 2017 — 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.

• InjuryMar 21, 2017Break; Break

  IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION OF THE RIGHT FIRST METATARSOPHALANGEAL JOINT (MTPJ) FUSION WAS PERFORMED ON (B)(6) 2017 DUE TO FAILED HARDWARE AND NON-UNION. A FUSION OF THE FIRST MTPJ WAS PERFORMED ON AN UNKNOWN DATE SIX WEEKS PRIOR DUE TO ARTHRITIS. SUBSEQUENTLY, WHEN THE PATIENT RETURNED FOR A FOUR WEEK FOLLOW-UP WITH THE SURGEON, IT WAS DISCOVERED VIA X-RAY THAT THERE WAS A NON-UNION AT THE MTPJ SITE AND THAT THE VARIABLE ANGLE (VA) FOREFOOT/MIDFOOT PLATE HAD BROKEN ON THE PROXIMAL SIDE THROUGH ONE OF THE VA LOCKING SCREW HOLES. THE SURGEON COMMENTED THAT THE PATIENT HAD BEEN COMPLIANT WITH POSTOPERATIVE WEIGHT-BEARING RESTRICTIONS, IS NOT OBESE AND HAS NO OTHER MEDICAL ISSUES. REMOVED HARDWARE INCLUDED ONE BROKEN PLATE, FOUR INTACT LOCKING SCREWS FROM THE PLATE, AND ONE INTACT 2.7MM CORTICAL SCREW ¿WHICH WAS PREVIOUSLY IMPLANTED INDEPENDENTLY AS PART OF THE ORIGINAL CONSTRUCT. THE REMOVAL WENT SMOOTHLY AND WITHOUT INCIDENT. NO FRAGMENTS WERE INVOLVED; THE BROKEN PLATE WAS REMOVED EASILY. NO REPORTED SURGICAL DELAY AND NO ADDITIONAL X-RAYS WERE REQUIRED. MTP REAMERS WERE USED TO GET GOOD QUALITY BONE. CULTURES WERE TAKEN AT THE OPERATIVE SITE TO RULE OUT IN

  Patient problems: Failure of Implant; Impaired Healing

  MAUDE report 6421602 ↗