M.U.S.T. Polyaxial Pedicle Screw 03.50.032Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030834301), received between Feb 23, 2018 and May 8, 2023 — classified as 3 injuries.

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 8, 2023Fracture; Migration; Fracture; Migration

  REVISION SURGERY DUE TO PSEUDOARTHROSIS L5/S1. ALL 4 SCREWS WERE TAKEN OUT. 2 WERE LOOSE (S1 AND L5 SCREWS), 1 WAS BROKEN (S1 LEFT). AT ABOUT 10 MONTHS FORM PRIMARY THE SCREWS WERE REPLACED WITH 8X 50MM FENESTRATED SCREWS, BUT NO CEMENT AUGMENTATION HAS BEEN MADE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16884699 ↗
• InjuryFeb 16, 2022Appropriate Device Problem Term/Code Not Available

  AT ABOUT 4 MONTHS AFTER THE PRIMARY, REVISION SURGERY PERFORMED DUE TO IMPLANT-ASSOCIATED EARLY LUMBAL INFECTION (STAPHYLOCOCCUS EPIDERMIS, CUTIBACTERIUM ACNES). SCREWS AND RODS WERE REVISED (L4-S1). THE CAGE WAS REPLACED WITH A COMPETITOR'S CAGE.

  Patient problems: Unspecified Infection

  MAUDE report 13542265 ↗
• InjuryFeb 23, 2018Break; Device Slipped

  THE PATIENT CAME IN FOR A REVISION OF A POSTERIOR FUSION OF L3-S1, 9 MONTHS AFTER PRIMARY. THE SCREWS WERE LOOSE. THE CAUSE IS UNKNOWN. THE SURGEON REMOVED THE SCREWS AND RODS. AFTER THE CASE THE AGENT NOTICED THAT 3 SET SCREWS OF THE L3-L4 SCREW WERE BROKEN. IT IS UNKNOWN IF THE SCREWS BROKE WHILE IN THE PATIENT OR UPON REMOVAL. THE SURGEON IMPLANTED ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY. FUSION WAS ACHIEVED IN 2 VERTEBRA YET NOT ACHIEVED AT L5-S1.

  Patient problems: No Code Available

  MAUDE report 7292581 ↗

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