OASYS 48555324Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540469557), received between Mar 5, 2018 and Nov 12, 2020 — classified as 2 injuries, 2 malfunctions.

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

Recent adverse event reports

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

• InjuryNov 12, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO OASYS PA MEDIAL SCREWS FRACTURED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED BUT THE BROKEN DEVICES REMAIN IMPLANTED IN THE PATIENT. THIS REPORT REPRESENTS THE FIRST OF THE TWO OASYS PA MEDIAL SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10833228 ↗
• InjuryNov 12, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO OASYS PA MEDIAL SCREWS FRACTURED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED BUT THE BROKEN DEVICES REMAIN IMPLANTED IN THE PATIENT. THIS REPORT REPRESENTS THE SECOND OF THE TWO OASYS PA MEDIAL SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10833163 ↗
• MalfunctionMay 6, 2019Break; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE 3.5 X 24 MM SCREW IMPLANTED IN T2 BROKE POST-OPERATIVELY. THE DEVICE REMAINS IMPLANTED. NO ADVERSE CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED WITH THIS EVENT AND REVISION SURGERY IS NOT PLANNED AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8584405 ↗
• MalfunctionMar 5, 2018Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SCREW WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2018, WHEN THE SCREW WAS REMOVED, DURING EXPLANATION AT RIGHT OF THE FOURTH CERVICAL VERTEBRA, THE DOCTOR FOUND THAT THE TULIP HEAD AND SCREW THREAD WERE SEPARATED. ONLY THE SCREW THREAD WAS LEFT IN THE BONE. THE BONE WAS SCARPED AND THE SCREW WAS REMOVED WITH PLIERS. THERE WAS A 50 MINUTE SURGICAL DELAY. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7314879 ↗