M.U.S.T. Rods 03.50.403Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030835360), received between Oct 4, 2017 and May 16, 2024 — 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.

• InjuryMay 16, 2024Fracture; Fracture

  REVISION SURGERY DUE TO ROD BREAKAGE (5.5 X 480 MM TI ROD) APPROXIMATELY 6 MONTHS AFTER THE LAST SURGERY. THE THORACIC PART OF THE PRIMARY RODS WAS LEFT IN THE PATIENT SINCE THERE WERE LAMINA BANDS ATTACHED TO IT. THE SURGEON THEN ADDED A ROD FROM THE COMPETITOR WHICH HAS A CONNECTOR ATTACHED TO IT TO THE THORACIC ROD. ADDITIONALLY, HE ADDED THE TWO PARALLEL RODS TO ADD MORE STABILITY. RODS AND SIDE-TO-SIDE CONNECTORS ARE FROM COMPETITORS. THE PATIENT HAD UNDERGONE 3 PREVIOUS SURGERIES TO EXTEND THE CONSTRUCT AND 2 PREVIOUS SURGERIES DUE TO INFECTION (NO MEDACTA DEVICES REVISED).

  Patient problems: Insufficient Information

  MAUDE report 19330278 ↗
• InjuryNov 10, 2021Break

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND X-RAYS REVEALED THAT THE ROD WAS BROKEN. THE SURGEON HAD TO REMOVE THE ROD AND 3 SCREWS 2 YEARS AND 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT IN ANY PAIN ONCE THE ROD BROKE. THE PATIENT WAS WORKING OUT 2-3 TIMES A DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12786545 ↗
• MalfunctionOct 4, 2017Device Packaging Compromised; Device Packaging Compromised

  THE INTERNAL PACKAGING WAS DAMAGED, THEREFORE THE STERILITY OF THE PRODUCT WAS COMPROMISED. THE SURGEON USED OTHER RODS TO COMPLETE THE SURGERY SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6913759 ↗

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