NA 388.151Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034772066), received between Sep 25, 2019 and Dec 24, 2025 — classified as 2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR SPINAL FUSION ON (B)(6) 2025. DURING THE INSERTION OF A COLLAR AND NUT ON THE USS SCREW, THE LIP OF THE COLLAR INSERTER BROKE OFF AT THE WELD POINT. THE CASE WAS STILL ABLE TO BE COMPLETED AND THE PATIENT WAS NOT HARMED, HOWEVER IT WAS INCONVENIENT TO THE SURGEON. NO SURGERY DELAYED DUE TO THE REPORTED EVENT. FRAGMENTS WERE GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887941 ↗
• MalfunctionSep 25, 2019Break; Break

  NO FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE. PROCEDURE WAS COMPLETED WITH A SECOND SIMILAR DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9120466 ↗