SMARTLOCK 55-10566Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540366276), received between Sep 21, 2018 and Jul 3, 2019 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2019Fracture; Material Twisted/Bent

  IT WAS REPORTED BY A SURGEON ALONG WITH A COMPANY REPRESENTATIVE THAT A PLATE FRACTURE WAS NOTICED AFTER A SURGICAL PROCEDURE HAD COMPLETED. THIS INITIAL PROCEDURE WAS REPORTED AS COMPLETED SUCCESSFULLY WITHOUT A DELAY. IT WAS ALSO NOTED THE PLATE THAT FRACTURED HAD BEEN BENT AND RE-BENT MULTIPLE TIMES DURING THE PROCEDURE. A REVISION SURGERY WAS PLANNED TO REMOVE THE FRACTURED PLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8758401 ↗
• InjurySep 21, 2018Break

  IT WAS REPORTED THAT THE PLATE BROKE THREE WEEKS AFTER IMPLANTATION AND REQUIRED A REVISION SURGERY TO EXTRACT THAT PLATE AND IMPLANT ANOTHER. NO ADDITIONAL ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 7899962 ↗