LONESTAR 83-9003Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 18257200086092), received between Nov 19, 2024 and Dec 12, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS BROKEN. THE DISTRIBUTOR REPORTED THAT THERE WAS A 40-50 MINUTE DELAY IN THE CASE. NO FURTHER CASE DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20917682 ↗
• MalfunctionNov 22, 2024Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TWO LEVEL ACDF ON (B)(6), WHILE INSERTING THE CAGE, THE TIP OF THE INSERTER BROKE INSIDE THE THREADS OF THE CAGE. IT WAS CONFIRMED THAT THERE WAS NO ADVERSE EFFECTS TO THE PATIENT AND SURGERY WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT THAT WAS INSIDE OF THE TRAY. IT WAS REPORTED THAT THERE WAS A 40-50 MINUTE DELAY IN THE CASE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759288 ↗
• MalfunctionNov 19, 2024Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TWO LEVEL ACDF ON (B)(6)2024, WHILE INSERTING THE CAGE, THE TIP OF THE INSERTER BROKE INSIDE THE THREADS OF THE CAGE. IT WAS CONFIRMED THAT THERE WAS NO ADVERSE EFFECTS TO THE PATIENT AND SURGERY WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT THAT WAS INSIDE OF THE TRAY. IT WAS REPORTED THAT THERE WAS A 40-50 MINUTE DELAY IN THE CASE. SEVERAL ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE WITH NO GOOD REULTS. THE DEVICE HAS NOT RETURNED FOR INVESTIGATION. WHEN THE DEVICE RETURNS AN INVESTIGATION WILL BE CONDUCTED ON THE DEVICE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727907 ↗