VA-LCP 02.127.221Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982043528), received between Apr 11, 2019 and Sep 15, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. 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.

• MalfunctionSep 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON WAS NOT ABLE TO GET A PROXIMAL TIBIA PLATE TO FIT PROPERLY, AND THEREFORE HAD TO PLACE IT MORE DISTAL THAN SHE WANTED. SHE WAS ULTIMATELY SATISFIED WITH THE OUTCOME. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY OR PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/6H/117MM/LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17757541 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SURGERY ON (B)(6) 2022 TO IMPLANT THE DEVICE. ON (B)(6) 2023, IT APPEARED THAT THE PATIENT HAD DEVELOPED A REACTION ISSUE WITH THE TITANIUM IN HIS LOWER LEG. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE UNK - PLATES: TITANIUM ALLOY (TAN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16589857 ↗
• InjuryFeb 3, 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 SURGEON WAS REMOVING A PLATE AND 9 SCREWS FROM THIS PATIENT. DURING THE REMOVAL 3 OF THE 3.5MM SCREW HEADS BROKE OFF INTO THE PATIENT. THESE 3 SCREWS REMAINED IN THE PATIENT. HE ALSO REMOVED A PLATE AND 6 SCREWS ALL OF WHICH WERE REMOVED SUCCESSFULLY. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. IT IS UNKNOWN IF THERE WERE SURGICAL DELAY AND PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/6H/117MM/LEFT. THIS IS REPORT 2 OF 10 (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273862 ↗
• InjuryApr 11, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF ONE (1) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) PROXIMAL TIBIA PLATE, SMALL BLEND, FOUR (4) VARIABLE ANGLE (VA) LOCKING SCREWS, FOUR (4) CORTEX SCREWS DUE TO INFECTION. ALL HARDWARE WAS INTACT. ORIGINAL IMPLANT WAS ON (B)(6) 2016. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/6H/117MM/LEFT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8503894 ↗