NA 207.630Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982148193), received between Feb 4, 2025 and Feb 4, 2025 — classified as 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, PATIENT WAS TREATED FOR BILATERAL PARS FRACTURE. SURGEON WAS USING 4.0 CANNULATED SCREWS (STAINLESS STEEL, SHORT THREAD) FOR THE PROCEDURE. BOTH WIRES WERE PLACED AND ONE SCREW WAS DRILLED AND PUT IN AT A TIME. THE FIRST SCREW WAS PLACED AND WAS LEFT IN POSITION. WHEN PUTTING IN THE SECOND SCREW, THE PRE-DRILL WAS DONE AND WHEN THE SCREW WAS GOING IN, THE THREADS OF THE SCREW CAME UNRAVELED. THE SCREW WAS THEN BACKED OUT BUT THE REST OF THE SCREW (THREADS) WERE STUCK IN THE PATIENT. THE WIRE WAS NEVER MOVED OUT OF POSITION AND REMAINED THE ENTIRE TIME AS THE SCREW WAS PLACED. DUE TO THIS COMPLICATION, THE PATIENT NOW NEEDED TO UNDERGO AN EMERGENCY LAMINECTOMY TO REMOVE THE REST OF THE SCREW FROM THE SPINAL CANAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 21307399 ↗