VA-LCP 02.118.209Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982038449), received between Mar 10, 2017 and Feb 10, 2021 — classified as 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2021Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11309127 ↗
• InjuryMar 27, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT SUFFERED A FRACTURE OF LEFT DISTAL TIBIA AND WAS TREATED WITH A VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) ANTEROLATERAL DISTAL TIBIA PLATE, SEVEN (7) 3.5 CORTEX SCREWS, AND SEVEN (7) 2.7 METAPHYSEAL SCREWS. PATIENT HAD A PREVIOUS TOTAL KNEE WHICH PREVENTED THE USE OF A TIBIA NAIL. ON AN UNKNOWN DATE, THE PATIENT RETURNED TO THE CLINIC WITH A BROKEN PLATE DUE TO NONUNION. PATIENT UNDERWENT REMOVAL OF ALL HARDWARE ON (B)(6) 2019 AND WAS REVISED WITH A NEW PLATE AND SCREWS. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: 3.5 CORTEX SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 7); 2.7 METAPHYSEAL SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 7) . THIS REPORT IS FOR A VA-LCP ANTEROLATERAL DISTAL TIBIA PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 8455735 ↗
• MalfunctionMar 5, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT INITIAL SURGERY IN 2015 TO TREAT DISTAL TIBIA FRACTURE. HARDWARE REMOVAL PROCEDURE WAS DONE ON (B)(6) 2019 DUE TO PAIN ON ANTERIOR SIDE. DURING THE HARDWARE REMOVAL PROCEDURE, THE VARIABLE ANGLE ANTEROLATERAL DISTAL TIBIA PLATE AND SCREWS WERE DIFFICULT TO REMOVE AND TWO (2) OF THE 2.7 SCREWS WERE BROKEN AND REMAINED IN THE PATIENT. THE IMPLANTS REMOVED WERE ONE (1) VARIABLE ANGLE ANTEROLATERAL DISTAL TIBIA PLATE, FOUR (4) 3.5 CORTEX SCREWS, ONE (1) 3.5 VA LOCKING SCREWS AND FIVE (5) 2.7 VA LOCKING SCREWS. ALL BONES HEALED AND NO SIGN OF ANY INFECTION. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT CAPTURES INTRAOPERATIVE ISSUE OF DIFFICULTY IN HARDWARE REMOVAL, WHILE RELATED COMPLAINT (B)(4) CAPTURES REMOVAL DUE TO POSTOP PAIN. THIS REPORT IS FOR ONE (1) 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PLATE. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8392556 ↗
• InjuryFeb 15, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED ON (B)(6) 2019, THE SURGEON SCHEDULED A REMOVAL OF A VARIABLE ANGLE ANTERLATERAL DISTAL TIBIA PLATE ON (B)(6) 2019 DUE TO PAIN. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN.THIS REPORT IS FOR ONE (1) 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/10 HOLES/LEFT THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 8345182 ↗
• InjuryMar 10, 2017Crack; Crack

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS AGO, A PATIENT WAS IMPLANTED WITH A VA-LCP DISTAL TIBIA PLATE, FIVE 2.7MM PROXIMAL SCREWS AND SIX 2.7MM DISTAL SCREWS TO TREAT A DISTAL TIBIA FRACTURE. SUBSEQUENTLY, THE PATIENT EXPERIENCED NONUNION. ON (B)(6) 2017 THE PATIENT UNDERWENT HARDWARE REMOVAL, TREATMENT WITH A REAMER ¿ IRRIGATOR ¿ ASPIRATOR TO GENERATE BONE GRAFT AND REPLACEMENT OF TIBIA HARDWARE. DURING SURGERY, IT WAS NOTED THAT THE PLATE WAS CRACKED AND THREE DISTAL SCREWS WERE BROKEN, ONE AT THE HEAD AND TWO AT THE SHAFT. ALL HARDWARE AND BROKEN SCREWS WERE REMOVED EASILY AND WITHOUT SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND PATIENT OUTCOME WAS REPORTED AS STABLE. AN INTRA-OPERATIVE EVENT WAS ALSO REPORTED, WHICH WILL BE CAPTURED IN AND REPORTED UNDER LINKED COMPLAINT (B)(4). CONCOMITANT DEVICES REPORTED: 2.7MM PROXIMAL SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY: 5) 2.7MM DISTAL SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY: 3). THIS REPORT IS FOR ONE (1) PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

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

  MAUDE report 6394685 ↗