VA-LCP 02.118.405Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982038883), received between Oct 1, 2018 and Sep 5, 2025 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS REQUESTING INFORMATION REGARDING ANY POTENTIAL RECALLS AND MATERIAL MAKEUP OF HER PLATE AND SCREWS DUE TO SYMPTOMS SHE IS EXPERIENCING SINCE THE IMPLANTATION IN (B)(6) 2016 FOR A BROKEN ANKLE AND TIBIA. SYMPTOMS BEGAN 9 MONTHS AFTERWARD AND INCLUDE HYPERSENSITIVITY, AN IMMUNE RESPONSE THAT HAS "MESSED UP HER SYSTEM," HIGH TITER, DISCOID LUPUS, SKIN ISSUES, BODY ACHES, FATIGUE, FEVERS, JOINT PAIN, STIFFNESS, REDNESS, AND EXTREME FATIGUE. PATIENT'S SURGEON WOULD LIKE TO PERFORM AN MRI AND POTENTIALLY REMOVE THE DEVICE.

  Patient problems: Fatigue; Fever; Hypersensitivity/Allergic reaction; Muscular Rigidity; Pain; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 22984724 ↗
• MalfunctionNov 21, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT ALLEGATIONS APPLIED TO BOTH THE LOCKING SCREWS LISTED AS WELL AS BOTH PLATES USED ON THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 20744406 ↗
• MalfunctionNov 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE 02.211.0XX 2.7MM VA LOCKING SCREWS WOULD NOT LOCK INTO THE CENTRAL POSTERIOR/ DISTAL HOLE OF THE 02.118.405 LEFT 5 HOLE VA DISTAL FIBULA PLATE. THE PROPER DRILL GUIDE AND TECHNIQUE WAS USED, BUT THE SCREW WOULD NOT LOCK NO MATTER WHAT THE SURGEON TRIED. SEVERAL ATTEMPTS AND DIFFERENT SCREWS WERE USED WITHOUT SUCCESS. THE SURGEON REMOVED THE PLATE AND SWITCHED TO A DIFFERENT PLATE, 02.118.407 AND THE SAME SCREW HOLE WOULD NOT LOCK. THE SURGEON LEFT THE HOLE EMPTY AND COMPLETED THE CASE. THERE WAS A SURGICAL DELAY WHILE PLATE WAS EXCHANGED, AND ALTERNATE SCREWS ATTEMPTED. PROBABLY 15 MIN DELAY. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 20675974 ↗
• MalfunctionJul 1, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, THE 2.7MM VARIABLE ANGLE LCP LATERAL DISTAL FIBULA PLATE HOLE WAS STRIPPED CAUSING NO UNKNOWN LOCKING SCREWS TO BE ABLE TO BE INSERTED IN THAT HOLE. HAD TO CHOOSE A NEW PLATE IN ORDER TO USE UNKNOWN LOCKING SCREWS. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/5 HOLES/LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12098658 ↗
• MalfunctionFeb 3, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021, AN UNKNOWN PROCEDURE WAS PERFORMED, RIA 2 WAS USED WITH REAMER HEAD AND THE TUBING SCRUNCHED UP DUE TO EXCESSIVE FORCE. THE REAMER HEAD BROKE. ON THE IPSILATERAL SIDE A DYNAMIC HIP SYSTEM (DHS) WAS INSERTED BUT THE LAG SCREW WAS RIPPED DURING INSERTION. ON THE CONTRALATERAL SIDE TWO DISTAL FIBULA PLATES ENDED UP CROSS THREADING THE VARIABLE ANGLE (VA) LOCKING HOLES. THERE WAS A SURGICAL DELAY OF 10 MINUTES. CONCOMITANT DEVICES REPORTED: RIA 2 BONE HARVESTING KIT 520MM STERILE (PART NUMBER 03.404.000S, LOT UNKNOWN, QUANTITY 1). 10.0MM REAMER HEAD FOR RIA 2 STERILE (PART NUMBER 03.404.016S, LOT UNKNOWN, QUANTITY 1). DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/95MM (PART NUMBER 280.295, LOT UNKNOWN, QUANTITY 1). 2.0MM THRDD GUIDE F/ 2.7MM SCR VA AND LCP (PART NUMBER 03.133.008, LOT UNKNOWN, QUANTITY 1). 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/7 HOLES/RIGHT (PART NUMBER 02.118.408, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES 1 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/5 HOLES/LEFT. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11272488 ↗
• MalfunctionDec 29, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, THE VARIABLE ANGLE LOCKING COMPRESSION PLATE HOLES WERE STRIPPED, A VARIABLE ANGLE CONE WAS USED IN THE VA DISTAL FIBULA PLATES, AND A LOCKING DRILL TOWER IN THE LARGE FRAGMENT PLATE. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: 4.5MM BROAD LCP® PLATE 7 HOLES/134MM (PART NUMBER 226.571, LOT UNKNOWN, QUANTITY 1), 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/3 HOLES/LEFT (PART NUMBER 02.118.401, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/5 HOLES/LEFT. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11088440 ↗
• InjuryMar 27, 2019Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO NONUNION, INFECTION AND BROKEN HARDWARE. ONE (1) BROKEN VARIABLE ANGLE LOCKING COMPRESSION PLATE MEDIAL DISTAL TIBIA PLATE 6 HOLES, ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE DISTAL FIBULA PLATE 5 HOLES, THREE (3) 3.5MM UNKNOWN CORTEX SCREWS, FOURTEEN (14) UNKNOWN VARIABLE ANGLE LOCKING SCREWS, SEVEN (7) 2.7MM UNKNOWN CORTEX SCREWS WERE REMOVED, AND APPLICATION RING FIXATOR WAS PERFORMED. ORIGINAL IMPLANT WAS ON (B)(6) 2018. THE PATIENT WAS WALKING ON BROKEN ANKLE LESS THAN A MONTH AFTER PRIMARY SURGERY AND FELT SOMETHING BREAK. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS GOOD. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8458435 ↗
• MalfunctionMar 15, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE DUE TO AN UNKNOWN REASON. THE VARIABLE ANGLE (VA) LOCKING SCREW HOLES FAILED; THE TWO OF THE MOST DISTAL INFERIOR VARIABLE ANGLE (VA) HOLES FAILED TO LOCK ON THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP). DIFFERENT SCREWS WERE ATTEMPTED WITH THE SAME RESULT. PROPER TECHNIQUE WAS APPLIED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A TWO (2) MINUTE SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: LOCKING SCREWS (PART/LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR A VARIABLE ANGEL LOCKING COMPRESSION (VA-LCP) LATERAL DISTAL FIBULA PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8425948 ↗
• InjuryOct 17, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION OF ANKLE ON (B)(6) 2018. WHILE USING THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) LATERAL DISTAL FIBULA PLATE, THE SURGEON WAS UNABLE TO SUCCESSFULLY LOCK THE THREE MOST DISTAL, POSTERIOR HOLES IN THE PLATE. THE APPROPRIATE DRILL BIT, DRILL GUIDE AND SCREWDRIVER AND TECHNIQUE WAS USED. THIS CAUSED UNSPECIFIED SURGICAL DELAY WHILE TRYING TO LOCK THE SCREWS, REMOVE THE SCREWS, RE-INSERT AND TRY DIFFERENT SCREWS (2.7MM METAPHYSEAL). THE DISTAL ANTERIOR SCREWS LOCKED, AND THE SURGEON DID NOT WANT TO REMOVE THE PLATE AS FRACTURE REDUCTION WAS ACHIEVED AND MORE HARM COULD POSSIBLY FOLLOW FOR REMOVING IT AND TRYING A DIFFERENT PLATE. PATIENT AND SURGICAL OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: DRILL BIT (PART/LOT NUMBER UNKNOWN, QUANTITY 1), DRILL GUIDE (PART/LOT NUMBER UNKNOWN, QUANTITY 1), SCREWDRIVER (PART/LOT NUMBER UNKNOWN, QUANTITY 1), DISTAL ANTERIOR SCREWS (PART/LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7974416 ↗
• InjuryOct 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A HARDWARE REMOVAL ON (B)(6) 2018 DUE TO A DRAINING WOUND. IT IS UNKNOWN WHEN THE DEVICES WERE IMPLANTED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND SURGICAL OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7924076 ↗