GALILEO® LEFTY TIGHTY™ CRT²™ LAG SCREW, LEFT, 10.5mm x 105mm 1192-105Recalls & reported problems
Advanced Orthopaedic Solutions, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848665036565), received between Jul 11, 2024 and Jul 11, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation2
- Material Deformation1
Patient problems
- Foreign Body In Patient2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2024Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation
ON 03/07/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT (2) 1192-105 TELESCOPING LAG SCREWS WOULD NOT ADVANCE INTO THE FEMORAL HEAD. THIS OCCURRED DURING AN IM NAIL LEFT HIP CASE ON (B)(6) 2024 UPON X-RAY REVIEW, IT WAS NOTICED THAT THE THREADS ON THE LAG SCREW WERE STRIPPED OFF OF THE SCREWS. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 19725184 ↗MalfunctionJul 11, 2024Material Fragmentation; Material Fragmentation
ON 03/07/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT (2) 1192-105 TELESCOPING LAG SCREWS WOULD NOT ADVANCE INTO THE FEMORAL HEAD. THIS OCCURRED DURING AN IM NAIL LEFT HIP CASE ON (B)(6) 2024 UPON X-RAY REVIEW, IT WAS NOTICED THAT THE THREADS ON THE LAG SCREW WERE STRIPPED OFF OF THE SCREWS. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED. ADDITIONAL INFORMATION RECEIVED ON 3/1/2024: NOT ALL THE DEBRIS WAS REMOVED FROM INSIDE THE PATIENT. THE CASE WAS COM[LETED USING REGULAR THREADED LAG SCREW.
Patient problems: Foreign Body In Patient
MAUDE report 19724863 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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