OASYS 48551044Recalls & reported problems
Stryker Corporation · SMALL MIDLINE OCCIPUT PLATE · Class 2 · Implant
All models of OASYS (60)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540616531), received between Aug 24, 2016 and Jul 20, 2022 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
- Material Separation2
- Break1
- Device Dislodged or Dislocated1
- Disconnection1
- Mechanical Problem1
Patient problems
- Injury3
- Pain2
- Fall1
- Neck Pain1
- Neuropathy1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 20, 2022Fracture; Material Separation; Fracture; Material Separation
IT WAS REPORTED THAT THE TULIPS OF AN OASYS OCCIPIT PLATE DISENGAGED POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED OR SCHEDULED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15070552 ↗InjuryDec 17, 2020Fracture; Fracture
IT WAS REPORTED THAT AN OASYS MIDLINE OCCIPUT PLATE FRACTURED AT THE TULIP APPROXIMATELY 5 MONTHS POST-OPERATIVELY. THE PATIENT DID NOT FUSE AND HAS EXPERIENCED NEUROLOGICAL EFFECTS AS A RESULT OF THIS EVENT. REVISION SURGERY HAS BEEN PERFORMED.
Patient problems: Neuropathy
MAUDE report 11030202 ↗InjuryMar 14, 2019Break; Fracture; Fracture
THE PORTION OF THE PLATE WHICH CAPTURES THE ROD HAS BROKEN OFF FROM THE PLATE. THE PATIENT HAS A NECK PAIN. A REVISION SURGERY WILL BE REQUIRED BUT NOT PLANNED YET.
Patient problems: Injury; Neck Pain; Pain
MAUDE report 8420211 ↗InjuryNov 13, 2018Fracture; Disconnection; Fracture
IT WAS REPORTED THAT THE TWO TULIPS ON PLATE HAVE DISCONNECTED FROM PLATE POST-OPERATIVELY. REVISION SURGERY WILL BE REQUIRED. THE PATIENT WAS EXPERIENCING PAIN.
Patient problems: Injury; Pain
MAUDE report 8065411 ↗InjuryAug 24, 2016Mechanical Problem; Material Separation; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT FELL AND THE ROD AND BLOCKERS SEPARATED FROM OCCIPITAL PLATE. PUT A COMPETITIVE PLATE ON AND REATTACHED TO SAME SCREWS.
Patient problems: Fall; Injury
MAUDE report 5901015 ↗
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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