M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System 03.65.659Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630971251496), received between Oct 16, 2024 and Oct 16, 2024 — classified as 1 malfunction.

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.

• MalfunctionOct 16, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING THE PRIMARY SPINE SURGERY, WHEN THE SURGEON WAS TAPPING THE S2AI SCREW, HE COULD ONLY GET THE SCREW TO SEAT 80%. WHEN HE TRIED TO REMOVE THE SCREW WITH THE SCREWDRIVER, THE SCREWDRIVER BROKE. THE SURGEON TRIED ANOTHER SCREWDRIVER TO REMOVE THE SCREW WHICH ALSO BROKE. THE SURGEON TOOK A SAW AND CUT THE HEAD OFF THE SCREW AND LEFT THE SHAFT IN THE PATIENT. ADDITIONALLY, ON THE SI SCREW, THE SURGEON TRIED TO ADVANCE THE SCREW, AND THE IMPLANT FAILED 1/3 OF THE WAY DOWN. THE IMPLANT SHEARD OFF INSIDE THE DRIVER. THERE WAS A 45-MINUTE DELAY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A CONSIGNMENT SET WAS UTILIZED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20464547 ↗