M.U.S.T. Polyaxial Pedicle Screw 03.50.031Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030834295), received between Apr 10, 2018 and Jan 26, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 2 YEARS AND 1 MONTH AFTER THE PRIMARY SPINE SURGERY, THE REVISION SURGERY WAS PERFORMED BECAUSE THE S SCREW (7X45) LOOSENED, CAME OUT FROM THE BONE, AND BONE FUSION DID NOT OCCUR. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A 8X50 SCREW.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16246868 ↗
• InjurySep 9, 2022Osseointegration Problem; Osseointegration Problem

  ABOUT 1 YEAR AND 6 MONTHS AFTER THE PRIMARY SURGERY, A REVISION SURGERY WAS PERFORMED DUE TO L3/4/5 SCREWS LOOSENING AND L4/5 NOT FUSION. IT IS UNKNOWN WHICH SCREW CAME LOOSE. THE L3-5 SCREW WAS REMOVED TO REPLACE THE CAGE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15390881 ↗
• MalfunctionJul 4, 2018Break

  SET SCREW (SPECIFIC LOT UNKNOWN) HAS BEEN BROKEN DURING TIGHTENING, SMALL PIECES REMAINED IN THE PATIENT'S WOUND. THE SET SCREW WAS REPLACED WITH A NEW ONE.WHEN THE SURGEON TIGHTENED THE SET SCREW AFTER IMPLANTATION OF THE PEDICLE SCREW 7X40 AT L5, HE DISCOVERED THE SET SCREW WAS BROKEN. HE REMOVED THE BROKEN PIECE OF THE SET SCREW, BUT SMALL PIECES (2 MM) REMAINED IN THE PATIENT BODY. THE SET SCREW WAS REPLACED WITH A NEW ONE, THE SURGEON DECIDED TO NOT RETRIEVE THE SMALL PIECES THAT REMAINED THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7662373 ↗
• InjuryApr 10, 2018Connection Problem

  REVISION SURGERY 1 YEAR AND 1 MONTH AFTER PRIMARY SURGERY (LEVELS WERE L3-4) DUE TO PAIN, THE VERTEBRAE DIDN'T FUSE, THE SURGEON REVISED L3-4. THE SCREWS AND RODS (NOT LOOSE) WERE REMOVED AND REPLACED. THE INTERBODY REMAINED IN THE PATIENT.

  Patient problems: Pain

  MAUDE report 7412276 ↗

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