LCP 02.112.085Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982033192), received between May 24, 2019 and Sep 20, 2021 — classified as 2 injuries.

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

• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A SHAFT FRACTURE FIXATION SURGERY UTILIZING A LCP SUPERIOR CLAVICLE PLATE. HARDWARE REMOVAL WAS DONE AS PATIENT COULD FEEL THE IMPLANT. THERE WAS A UNION OF FRACTURE FOR ABOUT 12 WEEKS DURATION AND NO POST-OPERATIVE COMPLICATIONS REPORTED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM LCP SUPERIOR CLAVICLE PLATE/8 HOLE/LEFT/115MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12502550 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, A CLAVICLE PLATE WAS REMOVED DUE TO SUSPECTED INFECTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A 3.5MM LCP SUPERIOR CLAVICLE PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8641688 ↗