M.U.S.T. Rods 03.50.401Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030835346), received between Dec 22, 2017 and Apr 20, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO TWO RODS BREAKAGE (T12-S1) AND MOBILIZATION OF TWO PEDICLE SCREWS AT S1, AT ABOUT 1 YEAR 8 MONTHS AFTER THE PRIMARY.

  Patient problems: Aseptic loosening

  MAUDE report 24924655 ↗
• InjuryMar 16, 2018Break; Break

  REVISION SURGERY PERFORMED DUE TO PAIN PROBABLY CAUSED BY A ROD BREAKAGE 1 YEAR AND 2 MONTHS AFTER PRIMARY. THE SURGEON REVISED 2 RODS AND 6 SCREWS. HE RE-IMPLANTED AT L2-PELIVIS. THE PATIENT HAD A PRIMARY ON 8 (B)(6) 2016. ON (B)(6) 2016 THE PATIENT FRACTURED AT L5, AND WAS HAVING PAIN AND WEAKNESS, SURGEON REMOVED ONE INTERBODY ONE 7X45 PEDICLE SCREW AND TWO RODS. (MDR 2016-00754). ON (B)(6) 2018 THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF PAIN WAS NOT DETERMINED.

  Patient problems: Pain; Weakness

  MAUDE report 7345188 ↗
• MalfunctionDec 22, 2017Incomplete or Missing Packaging

  DURING THE PACKAGING OPENING THE NURSE NOTICED THAT ONE OF THE PLASTIC BAG WELDING WAS MISSING. THE SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER ROD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7142936 ↗

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