OASYS 48555424Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540469625), received between Apr 23, 2020 and Mar 3, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2025Difficult to Insert; Detachment of Device or Device Component; Device Dislodged or Dislocated; Difficult to Insert; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT FOUR OASYS POLYAXIAL SCREWS WERE DIFFICULT TO INSERT AND THAT THE TULIPS OF ALL FOUR SCREWS DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWO HOUR SURGICAL DELAY. THIS REPORT CAPTURES THE THIRD OF FOUR OASYS SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21510797 ↗
• MalfunctionMar 3, 2025Difficult to Insert; Detachment of Device or Device Component; Device Dislodged or Dislocated; Difficult to Insert; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT FOUR OASYS POLYAXIAL SCREWS WERE DIFFICULT TO INSERT AND THAT THE TULIPS OF ALL FOUR SCREWS DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWO HOUR SURGICAL DELAY. THIS REPORT CAPTURES THE FOURTH OF FOUR OASYS SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21510794 ↗
• MalfunctionMar 3, 2025Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  IT WAS REPORTED THAT FOUR OASYS POLYAXIAL SCREWS WERE DIFFICULT TO INSERT AND THAT THE TULIPS OF ALL FOUR SCREWS DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWO HOUR SURGICAL DELAY. THIS REPORT CAPTURES THE FIRST OF FOUR OASYS SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21510701 ↗
• MalfunctionMar 3, 2025Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  IT WAS REPORTED THAT FOUR OASYS POLYAXIAL SCREWS WERE DIFFICULT TO INSERT AND THAT THE TULIPS OF ALL FOUR SCREWS DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWO HOUR SURGICAL DELAY. THIS REPORT CAPTURES THE SECOND OF FOUR OASYS SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21510698 ↗
• MalfunctionAug 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER INSERTING THE OASYS POLYAXIAL SCREW THE HEAD AND SCREW SEPARATED WHEN THE SURGEON TRIED TO PULL THE SCREW BACK SLIGHTLY INTRA-OPERATIVELY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED.  THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377683 ↗
• MalfunctionMay 1, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN OASYS POLYAXIAL SCREW TULIP DISENGAGED INTRA-OPERATIVELY. THE SURGEON INITIALLY ATTEMPTED TO INSERT THE SCREW TO THE RIGHT OF C7, BUT THE SCREW WOULD NOT ADVANCE TO THE DESIRED DEPTH. THE SURGEON THEN TRIED TO REMOVE THE SCREW BY USING A ROD AND BLOCKER TO HELICOPTER THE SCREW OUT, BUT THE SCREW HEAD DISENGAGED FROM THE SHAFT. THE REMAINING SCREW SHAFT WAS THEN REMOVED FROM THE SURGICAL SITE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY BY USING A REPLACEMENT SCREW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10018171 ↗
• InjuryApr 23, 2020Material Separation; Device Dislodged or Dislocated; Material Separation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN OASYS POLYAXIAL SCREW TULIP DISENGAGED POST-OPERATIVELY. X-RAYS CONFIRMED THAT THE SCREW HEAD HAD COME OFF AND THE IDEAL ALIGNMENT HAD BEEN LOST. REVISION SURGERY WAS PERFORMED TO RE-INSTALL THE ROD FOR CORRECTION. THE SURGEON REMOVED THE DISENGAGED SCREW, THEN REPLACED IT WITH A SCREW THAT WAS ONE SIZE LONGER.

  Patient problems: Dysphagia/ Odynophagia; Injury

  MAUDE report 9991050 ↗