M.U.S.T. Rods 03.50.451Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030835506), received between Mar 31, 2026 and Mar 31, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

1 other recall cover devices cleared under the same FDA submission (K121115); they may or may not involve this specific model.

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.

• InjuryMar 31, 2026Device Appears to Trigger Rejection

  AT1 YEAR 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE 5.5 X 40MM RODS TO RODS OF THE SAME SIZE, REVISED THE 6X45MM PEDICLE SCREWS TO THE SAME SIZE PEDICLE SCREWS, AND REVISED THE 6X50MM PEDICLE SCREW TO A 7X45MM PEDICLE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24738810 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121115. One submission often covers many models, so check the product and lot details in each record.

• Z-1023-2017 · Dec 7, 2016 · Terminated
  Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to