VA-LCP 02.118.008Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982037701), received between May 18, 2018 and Jul 21, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THAT ON AN UNKNOWN DATE, THERE WAS A REMOVAL OF HARDWARE FOR NON-UNION AND REVISION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/10 HOLES/RIGHT. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17374748 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 OF 14 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY PERFORMED ON AN UNKNOWN DATE, THE PATIENT HAD A REMOVAL OF HARDWARE PROCEDURE ON (B)(6) 2022 DUE TO NON UNION AND INFECTION. ACCORDING TO THE REPORT, THE PATIENT WAS NON-COMPLIANT THAT HE WOULD SCRATCH THE SURGICAL SITE REGULARLY CAUSING THE INFECTION. IT WAS FURTHER REPORTED THAT THE IMPLANTS WERE REMOVED AND AN EX FIX WAS PLACED. THE STATUS OF THE PATIENT POST-REMOVAL OF ALL HARDWARE WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 2.7/3.5 VA-LCP MED DSTL TIBIA PL/10 H/RT DEVICE. THIS COMPLAINT INVOLVES 14 DEVICES.

  Patient problems: Unspecified Infection

  MAUDE report 14167132 ↗
• InjuryMar 12, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT AN UNKNOWN REVISION PROCEDURE DUE TO AN ATROPHIC NON-UNION THAT ALSO RESULTED IN THE BREAKING OF THE PLATE NEAR TWO (2) SCREWS PROXIMAL TO THE DISTAL POSTURE OF 2.7 SCREWS AND ALSO ONE (1) SCREW WAS BROKEN. THE ORIGINAL OPERATION WAS PERFORMED ON MARCH 28, 2018 TO TREAT A RIGHT DISTAL TIBIA FRACTURE WITH A 10 HOLE RIGHT VARIABLE ANGLE MEDIAL DISTAL TIBIA PLATE, SEVEN (7) 2.7 VA LOCKING SCREWS, FOUR (4) 3.5 MM CORTEX SCREWS, TWO (2) 3.5MM LOCKING SCREWS, AND AN ARTHREX FIBULA NAIL. THE PROCEDURE AND PATIENT OUTCOMES ARE UNKNOWN. CONCOMITANT DEVICES: UNKNOWN 2.7 VA LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 6); UNKNOWN 3.5 CORTEX SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 4); UNKNOWN 3.5 LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/10 HOLES/RIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9824150 ↗
• InjuryJun 12, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION OF THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) MEDIAL DISTAL TIBIA PLATE DUE TO A BROKEN PLATE. THE PATIENT HAD A DISTAL THIRD TIBIA FRACTURE THAT WAS TREATED IN (B)(6) 2019, AND CAME BACK TO THE DOCTOR¿S OFFICE THIS WEEK. THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN DEVICE. THERE WAS NO SURGICAL DELAY REPORTED. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNK - SCREWS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/10 HOLES/RIGHT THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8692268 ↗
• InjuryMay 18, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED NON-UNION OF THE RIGHT TIBIA/FIBULA DUE TO VARIABLE ANGLE LOCKING COMPRESSION (LCP) MEDIAL DISTAL TIBIA PLATE THAT WAS BROKEN. THE PATIENT WAS ORIGINALLY IMPLANTED WITH ONE (1) TIBIA PLATE, NINE (9) LOCKING SCREWS AND TWO (2) CORTEX SCREWS ON (B)(6) 2017. THERE WAS NO SURGICAL DELAY REPORTED. NO FURTHER ADDITIONAL INFORMATION AVAILABLE. CONCOMITANT DEVICES REPORTED: LOCKING SCREWS (PART/LOT UNKNOWN, QUANTITY 9), CORTEX SCREWS (PART/LOT UNKNOWN, QUANTITY 2). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7526415 ↗