VA-LCP 02.118.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982037589), received between Apr 24, 2018 and Jun 12, 2018 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2018Adverse 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 PROCEDURE OF HER LOWER RIGHT TIBIA AND FIBULA ON (B)(6) 2018, DUE TO PAIN AND DISCOMFORT. THE PATIENT WAS ORIGINALLY IMPLANTED WITH TWO (2) PLATES AND EIGHTEEN (18) SCREWS. THE TIBIA PLATE AND TEN (10) OF THE SCREWS WERE IMPLANTED IN THE PATIENT¿S TIBIA, WHILE THE FIBULA PLATE AND THE REMAINING EIGHT (8) SCREWS WERE IMPLANTED IN HER FIBULA. THE SCREWS WERE REPORTED TO BE A COMBINATION OF 2.7MM VARIABLE ANGLE (VA) LOCKING SCREWS, 2.7MM METAPHYSEAL SCREWS, 3.5MM VA LOCKING SCREWS AND 3.5MM CORTEX SCREWS. IT IS UNKNOWN WHICH OF THE SCREWS WERE IMPLANTED WITH WHAT PLATE AND THE INDIVIDUAL QUANTITY OF EACH TYPE OF SCREW IS UNKNOWN. DURING THE (B)(6) 2018 PROCEDURE, A STARDRIVE SCREWDRIVER WAS DISCOVERED TO BE BROKEN. DUE TO THIS DISCOVERY, THE SURGEON DECIDED TO CUT THE HEAD OF THE SCREWS OFF IN ORDER TO REMOVE THE PLATES. THE SURGEON WAS ABLE TO REMOVE THE TIBIA PLATE USING THIS METHOD; HOWEVER, THE SHAFTS OF TWO (2) OF THE SCREWS REMAIN IN THE PATIENTS TIBIA. ANOTHER STARDRIVE SCREWDRIVER WAS USED TO REMOVE THE REMAINING IMPLANTS, SUCCESSFULLY COMPLETING THE PROCEDURE. THERE WAS A REPORTED ONE-HOUR DELAY AS THE SURGEON ATTEMP

  Patient problems: Discomfort; Pain

  MAUDE report 7594619 ↗
• InjuryMay 31, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANKLE HARDWARE REMOVAL ON (B)(6) 2018 IN ORDER TO DO AN ANKLE FUSION. THE VARIABLE ANGLE LOCKING COMPRESSION MEDIAL DISTAL TIBIA (VA-LCP MED DIS TIB) PLATE WAS BEING REMOVED AND IT WAS NOTICED THAT THE PLATE HAD BROKEN DISTALLY. IT WAS NON-DISPLACED, SO IT WAS NOT NOTICED BEFORE SURGERY. THE FRACTURE WAS FOUND TO BE A NON-UNION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, WITH NO REPORTED DELAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICES: TRAUMA SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A 2.7/3.5 MM VA-LCP MEDIAL DISTAL TIBIA PLATE/4 HOLES/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 7556795 ↗
• InjuryApr 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD TO UNDERGO A HARDWARE REMOVAL PROCEDURE ON (B)(6) 2018 DUE TO PAIN AND DISCOMFORT. IN ADDITION TO THE PAIN AND DISCOMFORT, THE PATIENT REPORTED BEING ABLE TO FEEL THE HARDWARE. THE PATIENT WAS ORIGINALLY IMPLANTED WITH TWO (2) PLATES, TWO (2) 4-HOLE VA MEDIAL DISTAL TIBIA, EIGHT (8) LOCKING SCREWS, SIX (6) CORTEX SCREWS, TWO (2) CANNULATED SCREWS, TWO (2) WASHERS AND A K-WIRE ON AN UNKNOWN DATE. ALL OF THE HARDWARE WERE REMOVED DURING THE APRIL 4 PROCEDURE. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT INVOLVES 8 DEVICES. THIS REPORT IS 3 OF 8 FOR (B)(4).

  Patient problems: Discomfort; No Code Available; Unspecified Infection

  MAUDE report 7454801 ↗