OrthoSolutions 'System26' Bone Screws OS900030-NSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05055662956030), received between Mar 10, 2020 and Mar 25, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2021No Apparent Adverse Event; No Apparent Adverse Event

  DURING AN ORIF ANKLE PROCEDURE, WHERE THE PATIENT REQUIRED TWO CANNULATED SCREWS BI-MALLEOLAR, IT WAS REPORTED THAT THE K-WIRE BROKE UPON INSERTION AND RETAINED IN THE PATIENT. THE REMNANT PORTION OF THE WIRE WAS DISCARDED BY THE HEALTHCARE FACILITY. THE SURGICAL PROCEDURE PROCEEDED SUCCESSFULLY, AND NO PATIENT INJURY WAS REPORTED. NO FURTHER COMPLICATIONS WHICH REQUIRED MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11567192 ↗
• InjuryMar 10, 2020Fracture; Fracture

  DURING A MIDFOOT FUSION PROCEDURE, IT WAS REPORTED THAT AFTER INSERTING THE 4MM HEADLESS SCREW UNDER POWER AND PERCUTANEOUSLY OVER THE K-WIRE, IT WAS FOUND THAT THE K-WIRE TIP HAD BROKEN IN THE SCREW AND THEREFORE RETAINED IN THE PATIENT. THE FRACTURED K-WIRE TIP WAS CONFIRMED TO HAVE BROKEN OFF VIA X-RAY. THE SURGICAL PROCEDURE PROCEEDED SUCCESSFULLY, AND NO PATIENT INJURY WAS REPORTED. NO FURTHER COMPLICATIONS WHICH REQUIRED MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 9812646 ↗

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;