VA-LCP 02.118.206Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982038388), received between Feb 1, 2017 and Oct 2, 2020 — classified as 4 injuries.

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

• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL WAS PERFORMED DUE TO PAIN. ONE (1) 2.7 MM VARIABLE ANGLE LOCKING SCREW 40MM WAS FOUND BROKEN DURING THE REVISION SURGERY. THIS WAS NOT KNOWN PRIOR TO THE SURGERY. ALL HARDWARE WAS COMPLETELY REMOVED EXCEPT THE 2.7 MM VARIABLE ANGLE LOCKING SCREW 4MM. THE HEAD OF THE SCREW WAS REMOVED BUT THE SHAFT OF IT REMAINED IN THE PATIENT. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/8 HOLES/RIGHT. THIS IS REPORT 5 OF 10 FOR (B)(4). THIS COMPLAINT INVOLVES TOTAL 23 DEVICES. (B)(4) REPORTS 10 DEVICES, ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10620512 ↗
• InjuryFeb 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL FROM ANKLE DUE TO INFECTED NONUNION ON (B)(6) 2019. HARDWARE REMOVED WAS ONE (1) LOCKING COMPRESSION PLATE ONE -THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/ 57MM, ONE (1) LOCKING COMPRESSION PLATE ONE -THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/ 93MM, ONE (1) 2.7MM VARIABLE ANGLE - LOCKING COMPRESSION PLATE, ONE (1) 2.4/2.7MM VARIABLE ANGLE - LOCKING COMPRESSION PLATE T-FUSION, ONE (1) 2.7/3.5MM VARIABLE ANGLE - LOCKING COMPRESSION PLATE ANTEROLATERAL, TWO (2) UNKNOWN 2.7 CORTEX SCREWS, FIFTEEN (15) UNKNOWN 2.7MM VA LOCKING SCREWS, TWO (2) UNKNOWN 3.5MM LOCKING SCREWS AND ELEVEN (11) UNKNOWN 3.5MM CORTEX SCREWS. THE SITE WAS I&D AND ANTIBIOTIC CEMENT WAS PLACED IN BONE VOID AND THEN A MAXFRAME WAS PLACED. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS STABLE. ORIGINAL IMPLANT DATE IS REPORTED AS (B)(6) 2018. THIS REPORT IS FOR ONE (1) 2.7/3.5MM VARIABLE ANGLE - LOCKING COMPRESSION PLATE ANTEROLATERAL. THIS IS REPORT 5 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 8362868 ↗
• InjuryOct 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE RIGHT VARIABLE ANGLE LOCKING COMPRESSION PLATE ANTEROLATERAL DISTAL TIBIA PLATE WAS REMOVED DUE TO INFECTION. A TOTAL OF THREE (3) 3.5MM LOCKING SCREWS, ONE (1) 3.5MM CORTEX SCREWS AND EIGHT (8) 2.7MM VARIABLE ANGLE LOCKING SCREWS WERE REMOVED. THE DEVICES WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. IRRIGATION AND DEBRIDEMENT WERE PERFORMED AS A MEDICAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME WAS FAIR TO GOOD. THIS REPORT IS FOR ONE (1) 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/8 HOLES/RIGHT THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7980465 ↗
• InjuryFeb 1, 2017Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A NONUNION AND PLATE BREAKAGE. THE INITIAL OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT PILON FRACTURE PROCEDURE WAS PERFORMED ON (B)(6) 2016. PATIENT WAS INITIALLY IMPLANTED WITH ONE (1) 2.7MM/3.5MM VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP), UNKNOWN QUANTITY OF 3.5MM CORTICAL SCREWS, AND AN UNKNOWN QUANTITY OF 2.7MM VA LOCKING SCREWS. DURING A FOLLOW UP VISIT ON AN UNKNOWN DATE, IT WAS DISCOVERED BY X-RAY THAT THE PLATE HAD BROKEN AND PATIENT HAD NONUNION. THE X-RAYS DID NOT SHOW ANY SCREW BREAKAGE. IT IS UNKNOWN HOW THE BREAKAGE AND NONUNION WERE DISCOVERED AND IF PATIENT REPORTED ANY ADVERSE EVENTS. PATIENT HAD REVISION SURGERY ON (B)(6) 2017. DURING REVISION SURGERY, IT WAS DISCOVERED THAT THE HEADS OF FOUR (4) 2.7MM VA LOCKING SCREWS HAD BROKEN DURING REMOVAL. IT IS UNKNOWN IF THE SCREWS BROKE PRIOR OR DURING REVISION SURGERY. NO FRAGMENTS WERE GENERATED DUE TO BROKEN DEVICES. THE IMPLANTS WERE EASILY REMOVED WITHOUT REQUIRING MEDICAL INTERVENTION. THE CORTICAL SCREWS AND REMAINING VA LOCKING SCREWS WERE REMOVED INTACT. PATIENT WAS REVISED TO ONE (1) 3.5MM LCP ANTERO-LATERAL PLATE AND UNKNOWN QUANTI

  Patient problems: Failure of Implant; Impaired Healing; No Code Available

  MAUDE report 6294243 ↗