AOS GALILEO™ LAG SCREW, RIGHT, 10.5mm x 90mm 1099-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00848665015836), received between Nov 27, 2019 and Apr 27, 2026 — classified as 2 injuries, 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AFTER THE INITIAL SURGERY ON (B)(6) 2026, A REVISION SURGERY WAS PERFORMED ON THE SAME DAY BECAUSE A LEFT TROCHANTERIC NAIL HAD BEEN MISTAKENLY IMPLANTED INSTEAD OF THE RIGHT TROCHANTERIC NAIL. THE REVISION SURGERY WAS FINISHED SUCCESSFULLY USING THE RIGHT TROCHANTERIC NAIL. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE. UPDATE 15-APR-2026 - FURTHER INFORMATION WAS RECEIVED: THE DISTRIBUTOR REPORTED THAT THE LABEL OF THE DEVICE WAS CORRECT. THE INCIDENT WAS CAUSED BY AN ERROR AT THE HOSPITAL. NO X-RAYS ARE AVAILABLE. THE INITIAL SURGERY AND THE REVISION SURGERY WERE PERFORMED IN THE SAME HOSPITAL THROUGH THE SAME SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 25001904 ↗
• MalfunctionJul 25, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 04/01/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS(B)(4) THAT AN 0857-100 GALILEO EXTRACTION TOOL WAS DAMAGED DURING THE CASE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM. ON 07/10/2024, DURING DEVICE EVALUATION OF THE RETURNED DEVICE, IT WAS FOUND THAT THE 0857-100 WAS STUCK INSIDE A 1099-090 GALILEO LAG SCREW, RIGHT, Ø10.5MMX90MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19831052 ↗
• MalfunctionAug 17, 2022Break

  IT WAS REPORTED ON (B)(6)2022 BY A FACILITY REPRESENTATIVE VIA PHONE THAT AN 1099-090 GALILEO SCREW LOCKING O-RING BROKE-OFF. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 15245108 ↗
• InjuryNov 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2019, AOS RECEIVED AN IMAGE OF A BROKEN GALILEO LAG SCREW, P/N 1099-100. THE LAG SCREW HAD BROKEN INSIDE OF THE PATIENT APPROXIMATELY 5 MONTHS SINCE THE INITIAL SURGERY THAT TOOK PLACE ON (B)(6) 2019. THE REASON FOR INITIAL SURGERY IS UNKNOWN AS NO X-RAYS FROM INITIAL SURGERY HAVE BEEN PROVIDED. THERE HAS BEEN NO FURTHER COMMUNICATION REGARDING THIS COMPLAINT DESPITE MULTIPLE REQUESTS TO THE SALES REPRESENTATIVE. BECAUSE OF THIS, A ROOT CAUSE FOR THIS BREAK IS UNKNOWN. IT CAN BE ASSUMED THAT THE IMPLANT BROKE FROM ONE OF TWO POSSIBLE REASONS. ONE OPTION IS A SECONDARY TRAUMA THAT CAUSED BOTH THE BREAKAGE OF THE FEMUR AND THE FAILURE OF THE IMPLANT. THE SECOND OPTION IS THAT THE FRACTURE DID NOT HEAL DUE TO THE LACK OF REDUCTION IN THE INITIAL FRACTURE. THE IMPLANT IS NOT DESIGNED AS A LOAD-BEARING DEVICE, BUT LOAD-SHARING; ONLY TO REGAIN STRUCTURE AND AID IN THE HEALING PROCESS. WITH IMPROPER REDUCTION, THERE WOULD BE NO BONE GROWTH TO SUPPORT THE LAG SCREW, THEREFORE THE LAG SCREW COULD FRACTURE. WITH NO ADDITIONAL INFORMATION OTHER THAN AN X-RAY, NO DEFINITE CONCLUSION CAN BE MADE. HOWEVER, A FAILURE AT 5 MONTHS POST-OPERATION IS NOT INDICATIVE OF AN ISSUE WITH THE IMPL

  Patient problems: Failure of Implant

  MAUDE report 9387388 ↗