OASYS 48552426Recalls & reported problems
Stryker Corporation · POLYAXIAL SCREW · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540371829), received between Sep 8, 2017 and Mar 5, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated2
- Break1
- Difficult to Insert1
- Difficult to Remove1
- Material Deformation1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Device Dislodged or Dislocated
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 A DENALI ADJUSTABLE TRANSVERSE CONNECTOR AND AN OASYS ROD ALSO MIGRATED. A REVISION SURGERY IS NOT CURRENTLY SCHEDULED BUT MAY BE PERFORMED. THIS REPORT CAPTURES THE POLYAXIAL SCREW.
Patient problems: Insufficient Information
MAUDE report 24519735 ↗MalfunctionMar 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21549409 ↗MalfunctionSep 8, 2017Material Deformation; Break; Difficult to Insert; Difficult to Remove; Material Deformation
IT WAS REPORTED THAT; WHILE INSERTING A SCREW, THE SCREW HEAD STRIPPED AND WE WERE UNABLE TO INSERT OR REMOVE THE SCREW.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6852868 ↗
Other Orthosis, cervical pedicle screw spinal fixation devices
- INFINITY™ Occipitocervical Upper Thoracic System 3604026Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation2 recalls1 report
- CONNECTOR 79-2003Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 360PT4022Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- CONNECTOR 79-2002Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604532Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604024Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- OASYS 48551000Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation45 reports
- YUKON OCT Spinal System 7601-05030VB Spine LLC · Orthosis, cervical pedicle screw spinal fixation15 reports
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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