OASYS 48556332Recalls & reported problems
Stryker Corporation · SMOOTH SHANK POLYAXIAL SCREW · Class 2 · Implant
All models of OASYS (60)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540469755), received between Aug 10, 2020 and Aug 10, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 10, 2020Fracture; Fracture
IT WAS REPORTED THAT AFTER A PATIENT PRESENTED WITH PAIN, AN MRI WAS PERFORMED AND AN OASYS POLYAXIAL SCREW WAS OBSERVED TO BE FRACTURED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED TO REMOVE THE BROKEN OASYS SCREW. DURING SURGERY IT WAS NOTICED THAT ANOTHER SCREW WAS FRACTURED ON THE RIGHT SIDE. THE BROKEN TULIPS OF BOTH SCREWS WERE REMOVED, HOWEVER, THE SURGEON WAS NOT ABLE TO REMOVE THE THREADS OF BOTH SCREWS. THE THREADED PART OF THE SCREWS REMAINED IN THE BONE AND NEW SCREWS WERE PLACED IN PARALLEL. THIS REPORT REPRESENTS THE OASYS SCREW.
Patient problems: Pain
MAUDE report 10387337 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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