NA 02.211.402Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982054821), received between Sep 22, 2020 and Aug 4, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 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.

• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO TREAT A RIGHT SEVERELY COMMINUTED FRACTURE WITH A CALCANEAL PLATE ON AN UNKNOWN DATE. NINE SCREWS WERE USED FOR FIXATION IN ADDITION TO NORIAN BONE CEMENT. SIX WEEKS POSTOPERATIVELY, THE PATIENT EXPERIENCED INFECTION, WHICH LED TO REOPERATION AND AMPUTATION. THIS REPORT INVOLVES ONE 2.7MM VA-LOCKING CALCANEAL PLATE MEDIUM 64MM RIGHT. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES 1 ADDITIONAL IMPACTED PRODUCT. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 17459280 ↗
• InjuryAug 4, 2023Migration; Migration

  ELEVEN TOTAL SCREWS PLUS THREE CANNULATED SCREWS WERE USED FOR FIXATION.

  Patient problems: Insufficient Information

  MAUDE report 17458429 ↗
• MalfunctionSep 22, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, WHILE REPAIRING A CALCANEUS THE SURGEON WAS INSERTING A LOCKING 2.7 SCREW PERCUTANEOUSLY THROUGH A SMALL INCISION IN THE SKIN. AFTER INSERTING THE SCREW, THE SURGEON REALIZED HE HAD MISSED THE VA CALCANEUS PLATE AND BURIED THE SCREW IN THE BONE. THE SURGEON ELECTED TO NOT RETRIEVE THE SCREW BURIED IN THE BONE. IN ANOTHER PORTION OF THIS CASE, THE SURGEON USED A VARIABLE ANGLE LOCKING HOLE MULTIPLE TIMES AND RESULTED IN THE SCREW LOCKING MECHANISM NO LONGER WORKING. THE SURGEON ENDED UP REMOVING THE SCREW. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: SCREWDRIVER (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), SCREWS: LOCKING (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 2). THIS REPORT INVOLVES 1 2.7MM VA-LOCKING CALCANEAL PLATE MEDIUM 64MM RIGHT. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10566033 ↗