VOLT 02.527.112Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982322142), received between Nov 21, 2025 and Jun 1, 2026 — classified as 3 malfunctions.

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.

• MalfunctionJun 1, 2026Device-Device Incompatibility

  IT WAS REPORTED MULTIPLE SCREWS WOULD NOT LOCK INTO THE PLATE. DIFFERENT LOCKING GUIDES AND TRAJECTORIES OF THE DRILL WAS TRIED. THEY ALSO TRIED A NEW PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FORTY-FIVE MINUTE DELAY, BUT IT WAS NOTED THE FIXATION WAS SUBOPTIMAL, BUT NOT OTHER MEDICAL INTERVENTION WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350315 ↗
• MalfunctionDec 15, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THE LOCKING SCREWS WERE CHIPPED AND CRACKED SO THEY WERE NOT ABLE TO BE ASSEMBLED OR USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803489 ↗
• MalfunctionNov 21, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SCREW PACKAGE WAS RECEIVED EMPTY. THE SCREW PACKAGE WAS OPEN AND SCREW WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622601 ↗