COALITION MIS 6136.1002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889095305395), received between Apr 3, 2024 and Jun 30, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionJun 30, 2026Fracture

  IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS BROKEN. THE SURGEON HAMMERED ANCHOR OVER THE IMPACTOR TO THE HARD BONE, IT RESULTED STRETCHING AND THE TIP OF THREADED ROD WAS BROKEN. ITS TIP WAS STILL STRUCK IN COALITION IMPLANT. THE IMPLANT IS STILL IN PATIENT AND THE BROKEN PIECE IS THREADED IN THE HOLD OF THE COALITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25669130 ↗
• MalfunctionMar 30, 2026Fracture

  IT WAS REPORTED THAT DURING SURGERY THE THREADS BROKE OFF THE THREADED ROD. WHEN THE SURGEON STARTED IMPACTING THE DRIVER TO PLACE THE SPACER, THE THREADS SNAPPED OFF. THE SURGEON FINISHED PLACING THE IMPLANT USING A TAMP AND THE SURGERY WAS COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24737405 ↗
• MalfunctionApr 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A CASE, AN COALITION MIS THREADED ROD BROKE AT THE TIP WHICH REMAINS IN THE PATIENT POST OPERATIVELY. THIS EVENT OCCURRED IN THE UNITED KINGDOM.

  Patient problems: Spinal Column Injury

  MAUDE report 19035885 ↗