GALILEO® LEFTY TIGHTY™ CRT²™ LAG SCREW, LEFT, 10.5mm x 120mm 1192-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848665036596), received between Jun 19, 2024 and Jun 19, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2024Component Missing; Component Missing

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 5030-000 LAG SCREW INSERTER PIN POPPED OUT DURING THE PROCEDURE, NOT ALLOWING THE SURGEON TO PROPERLY ENGAGE THE LAG SCREW LOCKING TOOL. UPON REMOVAL O THE 1192-120 LAG SCREW, IT WAS DETERMINED THAT IT WAS MISSING THE LOCKING RING. SURGEON MADE SURE IT HAD NOT BROKEN INSIDE THE PATIENT AND CONFIRMED IT DID NOT; THEREFORE DETERMINED IT WAS MISSING UPON OPENING PACKAGE. A SECOND LAG SCREW WAS USED AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN INTERTROCHANTERIC FRACTURE PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566242 ↗