OASYS 48552430Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540371836), received between May 10, 2016 and Mar 16, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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

• InjuryMar 16, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  A COMPANY REPRESENTATIVE REPORTED THAT THE HEAD OF AN OASYS POLYAXIAL SCREW FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN SURGICAL DELAY AND THE PATIENT EXPERIENCED SPINAL CORD CONTUSION, REQUIRING DURA REPAIR AND FURTHER HOSPITALIZATION.

  Patient problems: Spinal Cord Injury

  MAUDE report 16554371 ↗
• MalfunctionDec 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN OASYS POLYAXIAL SCREW NON BIASED TULIP DISENGAGED INTRA-OPERATIVELY. THE TULIP CAME OUT SEPARATELY FROM THE SHAFT, SO THE SCREW WAS TAKEN OUT AND REPLACED AFTER GREAT DIFFICULTY. THE LOCKING CAPS AND THE ROD HAD TO BE TAKEN OUT, WHICH INCREASED THE SURGERY TIME BY AN HOUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9531526 ↗
• MalfunctionMay 10, 2016Mechanical Problem; Device Operates Differently Than Expected; Mechanical Jam; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED THAT THE SCREW CAN NOT BE SCREWED INTO,CHANGE ANOTHER NEW ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5645145 ↗