OASYS 48552326Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540380524), received between Mar 3, 2016 and Mar 23, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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

Recent adverse event reports

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

• MalfunctionMar 23, 2021Material Separation; Material Separation

  A PHYSICIAN REPORTED THAT THE TULIPS OF TWO OASYS SCREWS, PLACED AT LEFT-SIDE C3 AND C4, BECAME DISENGAGED DURING EXPLANT SURGERY. THE DEVICES HAD BEEN IMPLANTED FOR APPROXIMATELY 10 YEARS AND WERE BEING REMOVED AS PART OF A PROCEDURE TO REPLACE THE OLDER DEVICES AND EXTEND THE CONSTRUCT. THE PHYSICIAN COULD NOT REMOVE THE SCREW SHAFTS AND ELECTED TO LEAVE THEM IMPLANTED AND BEGIN THE NEW, EXTENDED CONSTRUCT AT C5. THIS REPORT CAPTURES THE SCREW IMPLANTED AT C4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556106 ↗
• MalfunctionMar 23, 2021Material Separation; Material Separation

  A PHYSICIAN REPORTED THAT THE TULIPS OF TWO OASYS SCREWS, PLACED AT LEFT-SIDE C3 AND C4, BECAME DISENGAGED DURING EXPLANT SURGERY. THE DEVICES HAD BEEN IMPLANTED FOR APPROXIMATELY 10 YEARS AND WERE BEING REMOVED AS PART OF A PROCEDURE TO REPLACE THE OLDER DEVICES AND EXTEND THE CONSTRUCT. THE PHYSICIAN COULD NOT REMOVE THE SCREW SHAFTS AND ELECTED TO LEAVE THEM IMPLANTED AND BEGIN THE NEW, EXTENDED CONSTRUCT AT C5. THIS REPORT CAPTURES THE SCREW IMPLANTED AT C3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556102 ↗
• MalfunctionFeb 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  STRYKER REPRESENTATIVE REPORTED THAT DURING REMOVAL SURGERY, AN OASYS POLYAXIAL SCREW HEAD CAME OFF FROM MAIN SCREW. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9759456 ↗
• MalfunctionMar 3, 2016Mechanical Problem; Device Dislodged or Dislocated; Loose or Intermittent Connection; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON FOUND THE LOOSENING OF THE BLOCKER UPON X-RAY IMAGES. THEREFORE, THE SURGEON IS MONITORING THE PATIENT, AND IS PLANNING REVISION SURGERY.

  Patient problems: Injury; No Code Available

  MAUDE report 5478038 ↗