NA 02.210.122Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982052995), received between Jul 19, 2018 and Feb 10, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K071184, K100776, K102694); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE VARIABLE ANGLE LOCKING SCREW HAD TROUBLE LOCKING INTO VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) VOLAR DISTAL RADIUS PLATE. THE SCREW HOLE WAS LEFT EMPTY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.4MM VA LOCKING SCREW SDDRIVE 22MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13506730 ↗
• MalfunctionJul 23, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 2.7MM LOCKING SCREW AND 2.4 MM VA LOCKING SCREW WERE RECEIVED ON EMPTY SEALED PACKAGE. EACH OF THESE DEVICES WAS PROVIDED AS PART OF FIELD INVENTORY REPLENISHMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 2.4MM VA LOCKING SCREW SDDRIVE 22MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12217329 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A CONTACT DERMATITIS DUE TO AN ALLERGIC REACTION. INITIALLY, THE PATIENT WAS IMPLANTED WITH A VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) DISTAL RADIUS SYSTEM ON AN UNKNOWN DATE. THE PATIENT IS NOW TAKING STEROIDS FOR CONTACT DERMATITIS AND DOES NOT REQUIRE REVISION SURGERY. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS IS 5 OF 5 FOR REPORT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9856828 ↗
• MalfunctionJul 19, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A DISTAL RADIUS FRACTURE PROCEDURE THAT THE PATIENT UNDERWENT ON (B)(6) 2018, AN UNKNOWN VARIABLE ANGLE (VA) LOCKING SCREW WAS STRIPPED WHEN IT WAS PUT IN THE VA LOCKING COMPRESSION PLATE (LCP) TWO-COLUMN VOLAR DISTAL RADIUS PLATE. THERE WERE NO VISIBLE FRAGMENTS GENERATED FROM THE STRIPPED SCREW. THE SURGEON TOOK QUITE SOME TIME IN DECIDING TO LEAVE THE SCREW INSIDE, WHICH CAUSED AN APPROXIMATE THIRTY (30) MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, BUT IT IS UNKNOWN WHAT THE PATIENT OUTCOME WAS. CONCOMITANT DEVICE REPORTED: VA LCP TWO-COLUMN VOLAR DISTAL RADIUS PLATE 2.4MM (PART 02.111.631S, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7704484 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071184, K100776, K102694. One submission often covers many models, so check the product and lot details in each record.

• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-2057-2013 · May 31, 2013 · Terminated
  Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and
• Z-0956-2013 · Jan 11, 2013 · Terminated
  Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Cor