LCP 02.120.601Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982040084), received between Mar 27, 2018 and Jun 29, 2021 — classified as 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT HARDWARE REMOVAL OF A RIGHT FEMUR FOR OSTEOMYELITIS INFECTION. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2019. ALL HARDWARE WAS REMOVED EASILY. THERE WAS ONE (1) POSTOPERATIVELY BROKEN SCREW. NO FRAGMENTS WERE GENERATED FROM THE BROKEN IMPLANT. THERE WAS NO SURGICAL DELAY REPORTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR 1 3.5MM LOCKING ATTACHMENT PLATE FOR 4.5MM LCP PLATE/4 HOLES THIS IS REPORT 14 OF 15 FOR COMPLAINT (B)(4).

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

  MAUDE report 12088812 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT HARDWARE REMOVAL OF A RIGHT FEMUR FOR OSTEOMYELITIS INFECTION. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2019. ALL HARDWARE WAS REMOVED EASILY. THERE WAS (1) POSTOPERATIVELY BROKEN SCREW. NO FRAGMENTS WERE GENERATED FROM THE BROKEN IMPLANT. THERE WAS NO SURGICAL DELAY REPORTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR (1) 3.5MM LOCKING ATTACHMENT PLATE FOR 4.5MM LCP PLATE/4 HOLES. THIS IS REPORT 8 OF 15 FOR COMPLAINT (B)(4).

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

  MAUDE report 12088796 ↗
• InjuryMar 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF TWO 3.5 MM ATTACHMENT PLATES ,FIVE 5.0 MM LOCKING SCREWS, FOUR CABLES, ONE PLATE AND EIGHT 3.5 MM LOCKING SCREWS ON (B)(6) 2018 DUE TO INFECTION. A PUS CAME OUT WHEN PATIENT WAS OPENED. A REMOVAL AND DEBRIDEMENT WERE PERFORMED. THE HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2013. THE REVISION SURGERY WAS COMPLETED WITHOUT ANY COMPLICATIONS AND WITHOUT ANY SURGICAL DELAY. PATIENT STATUS FOLLOWING THE PROCEDURE WAS REPORTED AS STABLE. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS 6 OF 6 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7375113 ↗
• InjuryMar 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF TWO 3.5MM ATTACHMENT PLATES ,FIVE 5.0MM LOCKING SCREWS, FOUR CABLES, ONE PLATE AND EIGHT 3.5MM LOCKING SCREWS ON (B)(6) 2018 DUE TO INFECTION. A PUS CAME OUT WHEN PATIENT WAS OPENED. A REMOVAL AND DEBRIDEMENT WERE PERFORMED. THE HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2013. THE REVISION SURGERY WAS COMPLETED WITHOUT ANY COMPLICATIONS AND WITHOUT ANY SURGICAL DELAY. PATIENT STATUS FOLLOWING THE PROCEDURE WAS REPORTED AS STABLE. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS 2 OF 6 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7375064 ↗