OASYS 48552330Recalls & 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 07613154129867), received between Oct 25, 2017 and Apr 8, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (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.
Most reported problems
Device problems
- Detachment Of Device Component2
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient1
- No Information1
- 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.
MalfunctionApr 8, 2020Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THAT AN OASYS POLYAXIAL SCREW ¿ BIASED ANGLE TULIP DISENGAGED INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A REPLACEMENT SCREW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9938037 ↗MalfunctionOct 25, 2017Detachment Of Device Component
IT WAS REPORTED THAT; AFTER THE COMPLETION OF THE SURGICAL NAIL, THE SCREW DETACHED FROM THE NAIL HEAD.
Patient problems: No Information
MAUDE report 6976298 ↗MalfunctionOct 25, 2017Detachment Of Device Component
IT WAS REPORTED THAT; AFTER THE COMPLETION OF THE SURGICAL NAIL, SCREW THE SCREW SPIKE FROM THE NAIL HEAD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6976236 ↗
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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