M.U.S.T. Polyaxial Pedicle Screw 03.50.017Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030834202), received between Sep 21, 2018 and Sep 21, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.

• InjurySep 21, 2018Loose or Intermittent Connection; Migration

  THE PATIENT ALLEGED PAIN AND ABNORMAL FEELING A WEEK AFTER PRIMARY SURGERY (PLIF DUE TO L4 SPONDYLOLISTHESIS) . THE SURGEON CONFIRMED THAT THE CAGE MIGRATED. REVISION SURGERY PERFORMED TWO WEEKS AFTER THE PRIMARY AND THE SURGEON CONFIRMED THE SET SCREW AT L5 LEFT SIDE LOOSEN. THE SURGEON REPLACED THE CAGE AND ALL SET SCREWS.

  Patient problems: Pain

  MAUDE report 7897546 ↗

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