OASYS 48552324Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540371737), received between Mar 3, 2016 and Jun 13, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJun 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVISION SCOLIOSIS SURGERY THREE OASYS POLYAXIAL WERE DISCOVERED TO BE BROKEN APPROXIMATELY 9 YEARS POST-OPERATIVELY. THE BROKEN SCREWS WERE LEFT IN THE PATIENT'S VERTEBRA. THIS REPORT CAPTURES THE SECOND OF THE THREE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674736 ↗
• InjuryOct 18, 2017Break; Fracture; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT; LATERAL MASS SCREW FRACTURED ON THE SCREW SHAFT AT T1. UPDATE (B)(6): PATIENT CAME TO DOCTOR BECAUSE OF A C5-6 INFECTION.

  Patient problems: No Known Impact Or Consequence To Patient; Unspecified Infection

  MAUDE report 6957424 ↗
• MalfunctionMay 2, 2017Break; Device Slipped; Failure to Advance; Material Deformation; Material Deformation

  IT WAS REPORTED THAT; WHEN THE PLATE SCREW WAS IMPLANTED AT LEFT C2 AND ADVANCED MORE WITH SCREW DRIVER, THE SCREW WAS NOT ADVANCED AND THE SCREW HEAD WAS SLIPPED. THEREFORE, THE SCREW WAS CHANGED THE NEW SAME OTHER ONE AND THE OPERATION WAS CONTINUED. REPORTEDLY; THE PATIENT BONY SUBSTANCE WAS HEAVY AND THE THREAD WAS CUTTING WITH TAP, BUT THE THREAD WAS SHALLOW. THE SCREW THREAD HAS BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6537199 ↗
• InjuryMar 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 Information

  MAUDE report 5478034 ↗