VA-LCP 02.111.571SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982031907), received between May 26, 2022 and Sep 12, 2024 — classified as 1 injury, 2 malfunctions.

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 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.

• MalfunctionSep 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN POLYTRAUMA (ACETABULUM, BILATERAL WRISTS, AND TIBIAL NAIL), A FEW PRODUCTS DID NOT WORK. TWO SUPRAPATELLAR HANDLES WERE USED AND UNABLE TO CONNECT THE NAIL. DURING PLACEMENT OF A SACROILIAC SCREW, A LONG EX FIX SLEEVE WAS USED AS A DRILL GUIDE AND THREE WERE BENT. TWO EXTRA LONG VOLAR DISTAL RADIUS PLATES WERE USED AND TWO DISTAL SCREWS DID NOT LOCK IN EACH PLATE. THEY USED A LOCKING TOWER AND SALES REP BELIEVE IT HAD DAMAGED THREADS THAT DAMAGED THE LOCKING MECHANISM INS OF THE PLATE. THEY USED A STANDARD INITIALLY THEN SWITCHED TO NARROW. THERE WAS NO SURGICAL DELAY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20203122 ↗
• MalfunctionSep 20, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON REPORTED THAT THE PLATE DID NOT FIT THE PATIENT¿S ANATOMY. ADDITIONALLY, THE SURGEON CHOSE TO CROSS THE PHYSIS WITH THE DISTAL LOCKING SCREWS CONSIDERING THE FRACTURE EXTENDED INTO THE PHYSIS. THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) 2.4/2.7 VA 2C DRP NW 6HHD/7H SFT/105/L-S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15454086 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REMOVAL/REVISION SURGERY OF THE DISTAL RADIUS FOR UNKNOWN REASON AS PART OF 2 STAGE PLANNED PROCEDURE. REMOVAL OF CEMENT BLOCK FROM RADIAL SHAFT SECTION. TRANSPORT FIBULA TO RADIUS. FIX DISTAL RADIUS TO FIBULA TO ULNA WITH LONGER PLATE. THIS REPORT IS FOR (6) 2.4/2.7 VA 2C DRP NW 6HHD/7H SFT/105/L-S. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14518695 ↗