M.U.S.T. Rods 03.50.431Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030835421), received between Jul 18, 2019 and Jul 18, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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.

• MalfunctionJul 18, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  ONCE THE NURSE OPENED THE BOX OF THE IMPLANT (2 OF 200 MM RODS AND 1 OF 300 MM ROD), THE PACKAGING OF THE ROD (DOUBLE "PAPER") WAS BROKEN. ANOTHER ROD (5.5X300) WAS OPENED AND USED BUT, IN ORDER TO HAVE THE DESIRED DIMENSION, IT WAS CUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8802420 ↗

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