LCP 422.226Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982215147), received between May 3, 2017 and May 3, 2017 — 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 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 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 FOR REMOVAL OF HARDWARE DUE TO INFECTION AND A DELAYED UNION. THE PATIENT WAS ORIGINALLY IMPLANTED WITH ONE (1) TITANIUM LOCKING COMPRESSION PLATE-PROXIMAL LATERAL TIBIA AND EIGHT (8) SCREWS ON (B)(6) 2017 DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE TIBIA TO TREAT A FRACTURE. ON AN UNKNOWN DATE AFTER THE SURGERY THE PATIENT DEVELOPED AN INFECTION AND A MASS FORMED AT HIS KNEE. IT IS UNKNOWN WHETHER THE PATIENT HAD PAIN RELATED TO THE DIAGNOSIS OR WHEN HE SOUGHT MEDICAL ATTENTION. DURING THE REVISION THE PLATE AND EIGHT (8) SCREWS WERE REMOVED WHOLE AND INTACT AND THE MASS AT THE PATIENT¿S KNEE WAS DRAINED, IRRIGATED AND DEBRIDED. THE PATIENT RECEIVED ANTIBIOTICS. NEW HARDWARE WAS NOT IMPLANTED. THERE WAS NO SURGICAL DELAY. NO HARM WAS REPORTED TO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS 1 OF 9 FOR COM-(B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 6540682 ↗