M.U.S.T. Rods 03.50.452Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030835513), received between Dec 7, 2018 and Dec 7, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 16, 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.

• InjuryDec 7, 2018Fracture; Fracture

  FIRST SURGERY: (B)(6) 2018; STABILIZATION L5-S1 (6X40 SCREWS AND 45MM TI PREBENT RODS). AFTER 3 MONTHS FROM FIRST SURGERY, A TAC EXAM REVEALED THE BREAKAGE OF THE RIGHT ROD AND THE LEFT SCREW IN S1. THE PATIENT WAS RE-OPERATED ON (B)(6): REMOVAL OF ALL SCREWS AND ROD (THE DISTAL PART OF THE BROKEN SCREW REMAINS IN THE SACRUM) AND FIXATION L4-S1 WITH COMPETITOR STABILIZATION SYSTEM.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant

  MAUDE report 8141712 ↗

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