M.U.S.T. Rods 03.50.454Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030835537), received between Jun 28, 2023 and Jun 28, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2023Break; Break

  AT ABOUT 8 MONTHS AFTER PRIMARY (SPONDYLODESE), REVISION SURGERY PERFORMED DUE TO LEFT BENT ROD TI 5.5X55MM BREAKAGE. THE SURGEON REVISED SUCCESSFULLY LEFT BROKEN ROD AND RIGHT ROD. PEDICLE SCREWS REMAINED STABLE. NO INFECTION. THE SURGEON ALSO PROCEEDED TO EXTEND THE PATIENTS CONSTRUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17215113 ↗

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