OASYS 48552240Recalls & reported problems
Stryker Corporation · ROD · Class 2 · Implant
All models of OASYS (60)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540371652), received between Nov 26, 2019 and Mar 5, 2026 — classified as 2 injuries, 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Migration1
Patient problems
- Injury2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Migration
A COMPANY REPRESENTATIVE REPORTED THAT THE TULIP OF AN OASYS POLYAXIAL SCREW DISENGAGED POST-OPERATIVELY. UPON REVIEW OF X-RAY IMAGING PROVIDED, IT WAS OBSERVED THAT AN OASYS CONNECTOR AND AN OASYS ROD ALSO MIGRATED. A REVISION SURGERY IS NOT CURRENTLY SCHEDULED BUT MAY BE PERFORMED. THIS REPORT CAPTURES THE ROD.
Patient problems: Insufficient Information
MAUDE report 24519738 ↗InjurySep 1, 2020Fracture; Fracture
A PHYSICIAN REPORTED THAT A PATIENT EXPERIENCED POST-OPERATIVE FRACTURE OF AN OASYS ROD. THE PATIENT HAS BEEN HOSPITALIZED. REVISION SURGERY HAS OCCURRED.
Patient problems: Injury; No Clinical Signs, Symptoms or Conditions
MAUDE report 10478542 ↗InjuryNov 26, 2019Fracture; Fracture
PHYSICIAN REPORTED AN OASYS 3.5 X 240 MM ROD FRACTURED POST-OPERATIVELY. REVISION SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2019.
Patient problems: Injury
MAUDE report 9379807 ↗
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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 16, 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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