VOLT 02.527.116Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982322289), received between Sep 11, 2025 and Jun 1, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• 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 25350462 ↗
• 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 23803505 ↗
• MalfunctionSep 11, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT POSTOPERATIVELY, WHILE REMOVING A 2.7MM VOLT CORTEX SCREW FROM THE PATIENT'S RADIUS, THE HEAD OF THE SCREW WAS SHEARED OFF. IN THE SAME CASE, THE HEAD OF ANOTHER 2.7MM VOLT CORTEX SCREW WAS SHEARED OFF UPON INSERTION AND TIGHTENING. THERE WAS A SURGICAL DELAY OF 10 MINUTES. THE BROKEN SCREW SHAFTS REMAINED IN PATIENT'S RADIUS.

  Patient problems: Foreign Body In Patient

  MAUDE report 23025323 ↗