VA-LCP 02.118.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982037626), received between Oct 18, 2018 and Oct 25, 2019 — 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 18, 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.

• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD A NONUNION ON THE DISTAL TIBIA WITH A MEDIAL DISTAL TIBIA PLATE. A TOTAL OF FIVE DISTAL SCREWS WERE BROKEN, FOUR (4) UNKNOWN 2.7 MM VA LOCKING SCREWS AND ONE (1) 3.5 MM CORTICAL SCREW. TWO SCREW FRAGMENTS WERE LEFT IN THE BONE. PATIENT WAS TREATED FOR THE NONUNION TODAY WITH ANTIBIOTIC BEADS AND WILL COMEBACK FOR A FOLLOW UP SURGERY AT A LATER DATE. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS IS 1 OF 6 FOR REPORT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9240797 ↗
• InjuryOct 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE DUE TO PAIN ON (B)(6) 2018. HARDWARE REMOVED DURING THE PROCEDURE INVOLVES ONE (1) LOCKING COMPRESSION PLATE (LCP) ONE-THIRD TUBULAR PLATE WITH COLLAR, ONE (1) VARIABLE ANGLE LCP MEDIAL DISTAL TIBIA PLATE, SEVEN (7) CORTEX SCREWS, TWO (2) LOCKING SCREWS WITH STARDRIVE AND FIVE (5) VARIABLE ANGLE LOCKING SCREWS WITH T8 STARDRIVE. THE HARDWARE WAS IMPLANTED ON AN UNKNOWN DATE. DURING THE PROCEDURE THE FIVE (5) VARIABLE ANGLE LOCKING SCREWS BROKE. THE BROKEN SCREWS WERE FULLY REMOVED. THE BONE WAS HEALED AND NO ADDITIONAL HARDWARE WAS IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT ADDRESSES THE REVISION SURGERY DUE TO PAIN. ADDITIONAL PRODUCTS INVOLVED ARE ADDRESSED IN (B)(4). THE INTRAOPERATIVE ISSUE WITH THE BROKEN SCREWS IS ADDRESSED IN (B)(4). THIS REPORT IS FOR ONE (1) 2.7/3.5MM VA LCP MEDIAL DISTAL TIBIA PLATE. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7978734 ↗