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EXPEDIUM 279729061Recalls & reported problems

Medos International Sàrl · EXPEDIUM SPINE SYSTEM PEDICLE MARKER PIN, SPHERE · Class 1

All models of EXPEDIUM (291)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034199672), received between May 12, 2021 and May 12, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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 16, 2026.

Most reported problems

Device problems

  • Material Deformation2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 12, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT ON (B)(6) 2021, DURING A SPINAL FUSION SURGERY WHEN PLACING THE PEDICLE MARKER AT S1 ON THE RIGHT SIDE, THE SHORTER PORTION OF THE MARKER BENT. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM PEDICLE MARKER PIN, SPHERE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11813037 ↗
  • MalfunctionMay 12, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT ON (B)(6) 2021, DURING A SPINAL FUSION SURGERY WHEN PLACING THE PEDICLE MARKER AT S1 ON THE RIGHT SIDE, THE SHORTER PORTION OF THE MARKER BENT. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM PEDICLE MARKER PIN, SPHERE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11812923 ↗

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Sources and updates

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