OrthoSolutions 'System26' Bone Screws OS900041-NSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055662956146), received between Oct 2, 2017 and Oct 2, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Corroded” (1 report).

1 other recall cover devices cleared under the same FDA submission (K163489); 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.

• MalfunctionOct 2, 2017Corroded; Material Erosion; Device Operational Issue; Corroded; Material Erosion; Device Operational Issue

  BROWN RESIDUE WAS FOUND INSIDE THE CANNULATION OF THE DRILLS. IT WAS FOUND DURING CLEANING AND WAS NOT USED ON THE PATIENT. ORTHO SOLUTIONS HAVE SINCE CONDUCTED A SERIES OF TEST AND THE RESIUDE WAS IDENTIFIED AS EARLY STAGE RUST. CURRENTLY ROOT CASE BEING INVESTIGATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6908391 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163489. One submission often covers many models, so check the product and lot details in each record.

• Z-0967-2018 · Oct 10, 2017 · Terminated
  SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS; OS900048-NS; OS900045-NS; OS900046-NS;