NA 241.618Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982167361), received between Feb 8, 2018 and Feb 8, 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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HARDWARE REMOVAL WAS PERFORMED ON (B)(6) 2018 DUE TO PATIENT PAIN AND POSSIBLE INFECTION, THERE WAS ALSO DRAINAGE AT THE SURGICAL SITE. A LOCKING CALCANEAL PLATE, 12 LOCKING SCREWS AND ONE CORTICAL SCREW WERE REMOVED. ALL PARTS WERE INTACT, NO MALFUNCTIONS. NO REVISION SURGERY WAS PERFORMED, NO ADDITIONAL X-RAYS WERE TAKEN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAYS AND THE PATIENT STATUS WAS NOTED AS STABLE. THE ORIGINAL SURGERY WAS FOR AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF A CALCANEUS FRACTURE. THE ORIGINAL SURGERY DATE IS UNKNOWN BUT WAS PERFORMED APPROXIMATELY SEVEN YEARS PRIOR TO REMOVAL. THIS REPORT IS FOR ONE (1) LOCKING CALCANEAL PLATE MINI-RIGHT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7252933 ↗