LCP 423.409Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982215987), received between Jun 21, 2022 and Jun 21, 2022 — 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. 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.

• InjuryJun 21, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT UNDERWENT ORIF SURGERY FOR A TIBIAL SHAFT FRACTURE WITH THE PLATE IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS CONFIRMED VIA X-RAY THAT NO MALFUNCTION HAD OCCURRED UNTIL (B)(6) 2022. ON AN UNKNOWN DATE IN (B)(6) 2022, THE BREAKAGE OF THE PLATE WAS CONFIRMED AND REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2022. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR A 3.5MM TI LCP® METAPHYSEAL PLATE 9 HOLES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14760080 ↗