VA-LCP 02.118.205Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982038364), received between Jun 1, 2017 and Mar 17, 2023 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT REVISION DUE TO SWELLLING, INFECTION(SEPSIS), PAIN AND IMPLANT FAILURE. XRAY AND ULTRASOUND CONFIRMED THAT THE HARDWARE IN HIS ANKLE HAS FAILED. THE PATIENT IS CURRENTLY TAKING BOTH ORAL AND IV ANTIBIOTICS. ON (B)(6) 2021 THE PATIENT WAS IMPLANTED WITH SYNTHESE DEVICES ON LEFT ANKLE AFTER FALLING FROM A TREE. THIS REPORT IS FOR ONE (1) 2.7/3.5 VA ANTEROLAT DSTL TIB PL/6 H/LFT THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16568761 ↗
• MalfunctionAug 22, 2022Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON 25-JULY-2022, THE SALES REP WAS PUTTING THE DEVICES TOGETHER AND NOTICED SIGNIFICANT DIFFERENCES IN THE FINISHES. THE FINISHING ON THE ANTERO LATERAL AND DISTAL FIBULA PLATES DO NOT LOOK CONFORMING WHEN COMPARED TO THE SMOOTH FINISHING OF THE MEDIAL DISTAL PLATE. IT WAS REPORTED AS LOOKING LIKE THERE WAS A WATER MARK THAT COULD NOT BE RUBBED OFF. THERE WAS NO REPORTED PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/6 HOLES/LEFT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266375 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF THE LOCKING COMPRESSION PLATING SYSTEM (LCP) OF THE DISTAL TIBIA DUE TO INFECTION. INITIALLY, THE PATIENT WAS IMPLANTED WITH AN LCP SYSTEM ON (B)(6) 2018. THE SURGEON COMMENTED THAT THE PATIENT HAD DEVELOPED SKIN ULCERS EARLY ON, WHICH CAUSED INFECTION FROM WEARING HIS POST-OP BOOT TOO TIGHT. THE HARDWARE WAS REMOVED, AND THE REMOVAL SURGERY WAS COMPLETED. THE PATIENT IS OK. CONCOMITANT DEVICES REPORTED: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM (PART NUMBER 241.351, LOT UNKNOWN, QUANTITY 1), 3.5MM LCP DISTAL TIBIA T-PLATE 3 HOLE/64MM (PART NUMBER 02.112.203, LOT UNKNOWN, QUANTITY 1), SCREWS: LOCKING (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 11) SCREWS: CORTEX (PART NUMBER UNKNOWN, LOT UNKNOWN QUANTITY 9). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4). (B)(4) CAPTURES THE 10 OF 23 DEVICES, (B)(4) CAPTURES THE 10 OF 23 DEVICES, AND (B)(4) CAPTURES THE 3 OF 23 DEVICES. THIS REPORT INVOLVES ONE (1) 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/6 HOLES/LEFT. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Ulcer; Unspecified Infection

  MAUDE report 10233297 ↗
• InjuryFeb 26, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE. DURING THE PROCEDURE, THE VARIABLE ANGLE (VA) DISTAL LOCKING SCREWS IN THE LEFT 6-HOLE ANTERIOR LATERAL DISTAL TIBIA PLATE STRIPPED. ANOTHER PLATE WAS USED AND THE SAME THING OCCURRED LEAVING ONLY THREE SCREWS IN THE DISTAL PORTION OF THE FRACTURE. THERE WAS A ONE HOUR SURGICAL DELAY. THE PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: LOCKING (PART# UNKNOWN, LOT# UNKNOWN, QTY 1), 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/6 HOLES/LEFT (PART# 02.118.205, LOT# UNKNOWN, QTY 1). THIS REPORT IS FOR ONE (1) 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/6 HOLES/LEFT. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9758334 ↗
• InjuryFeb 26, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE. DURING THE PROCEDURE, THE VARIABLE ANGLE (VA) DISTAL LOCKING SCREWS IN THE LEFT 6-HOLE ANTERIOR LATERAL DISTAL TIBIA PLATE STRIPPED. ANOTHER PLATE WAS USED AND THE SAME THING OCCURRED LEAVING ONLY THREE SCREWS IN THE DISTAL PORTION OF THE FRACTURE. THERE WAS A ONE HOUR SURGICAL DELAY. THE PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: LOCKING (PART#: UNKNOWN, LOT#: UNKNOWN, QTY 1); 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/6 HOLES/LEFT (PART#: 02.118.205, LOT#: UNKNOWN, QTY: 1). THIS REPORT IS FOR ONE (1) 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/6 HOLES/LEFT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9758320 ↗
• InjuryNov 16, 2017Break; Break

  IT WAS REPORTED THAT PATIENT HAD A REVISION SURGERY ON (B)(6) 2017 FOR A NON-UNION AND A BROKEN 2.7MM / 3.5MM VARIABLE ANGLE 6 HOLE LEFT PLATE OF A DISTAL TIBIA. SURGEON REMOVED THE PLATE AND ASSOCIATED SCREWS. PATIENT WAS IMPLANTED WITH A NEW 3.5MM CANNULATED ANGLED BLADE PLATE. THERE WAS NO DELAY IN SURGERY, PATIENT'S OUTCOME WAS AS PLANNED. SURGERY WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES ONE DEVICE. CONCOMITANT DEVICES REPORTED: SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7037488 ↗
• InjuryJun 1, 2017Break; Break

  IT WAS REPORTED A LEFT TIBIAL REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 AS THE PLATE BROKE POSTOPERATIVELY IN HALF AT THE FRACTURE SITE DUE TO A NONUNION. NO FRAGMENTS WERE GENERATED. NO SCREWS WERE IMPACTED. THE PATIENT WAS REVISED WITH A MEDIAL DISTAL TIBIAL PLATE. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. CONCOMITANT DEVICES REPORTED: SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 6604950 ↗