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OASYS 48558536Recalls & reported problems

Stryker Corporation · NON-BIASED POLYAXIAL SCREW · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540596468), received between Mar 17, 2017 and Apr 18, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component2
  • Material Separation2
  • Device Dislodged or Dislocated1
  • Device Slipped1
  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 18, 2022Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

    A COMPANY REPRESENTATIVE REPORTED THAT THE TULIPS OF TWO OASYS POLYAXIAL SCREWS DISENGAGED DURING IMPLANTATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER AN UNSPECIFIED DELAY. THIS REPORT CAPTURES THE FIRST OF TWO OASYS POLYAXIAL SCREWS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14138402 ↗
  • MalfunctionApr 18, 2022Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

    A COMPANY REPRESENTATIVE REPORTED THAT THE TULIPS OF TWO OASYS POLYAXIAL SCREWS DISENGAGED DURING IMPLANTATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER AN UNSPECIFIED DELAY. THIS REPORT CAPTURES THE SECOND OF TWO OASYS POLYAXIAL SCREWS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14138400 ↗
  • MalfunctionMar 17, 2017Mechanical Problem; Device Slipped; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE TULIP POPPED OFF OF SCREW DURING REMOVAL. A LOCKING SCREW DRIVER WAS BEING USED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6413123 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.