OASYS 48552322Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540371720), received between Mar 17, 2017 and Mar 28, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT AFTER A REVISION SURGERY FOR OASYS BLOCKER AND SCREW MIGRATION, IT WAS NOTICED THAT ONE OASYS POLYAXIAL SCREW HAD FRACTURED. RE-REVISION IS NOT SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991044 ↗
• 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 THIRD OF THE THREE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674738 ↗
• 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 FIRST OF THE THREE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674737 ↗
• MalfunctionMay 20, 2020Material Separation; Device Dislodged or Dislocated; Material Separation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN OASYS POLYAXIAL SCREW TULIP DISENGAGED INTRA-OPERATIVELY. THE SURGEON ATTEMPTED TO PULL OUT THE SCREW AT WITH A SCREWDRIVER, BUT IT WAS TOO HARD TO PULL OUT. SO, HE THEN USED A SHORT ROD AND TIGHTENED IT WITH A BLOCKER AND TRIED TO PULL IT OUT, BUT THE SCREW HEAD CAME OFF. THE SURGEON LEFT THE FRACTURED SHAFT IN THE PATIENT.

  Patient problems: Fall; No Consequences Or Impact To Patient

  MAUDE report 10075560 ↗
• MalfunctionMar 17, 2017Break; Detachment Of Device Component; Disassembly; Mechanical Problem; Disassembly; Mechanical Problem

  IT WAS REPORTED THAT THE HEAD BROKE OFF THE TULIP SCREW DURING THE CASE. THE FURTHER REPORTED THAT THE CONSTRUCT HAD BEEN LOCKED DOWN WITH THE ROD AND THE BLOCKER. THE SURGEON THEN CHECKED ON X-RAY AND WANTED TO CHANGE THE DIRECTION OF THE TULIP HEAD. WHEN HE TRIED TO ADJUST IT THE HEAD BROKE OFF THE SCREW. THE TULIP HEAD WAS REMOVED WITH FORCEPS AND THE SURGEON WAS ABLE TO UNWIND THE THREAD FROM THE BONE. NO UNINTENDED METAL WAS LEFT IN THE PATIENT. THE BONE WAS GOOD QUALITY AND THERE WERE NO OTHER OBVIOUS ISSUES. A NEW SCREW WAS INSERTED AND THE CASE WAS COMPLETED SUCCESSFULLY WITH NO LASTING CONSEQUENCES FOR THE PATIENT. THERE WAS A 30 MINUTE DELAY TO SURGERY AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6413754 ↗