OASYS 48551045Recalls & reported problems
Stryker Corporation · MEDIUM 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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540616548), received between Mar 8, 2016 and Jul 31, 2023 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 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
- Fracture5
- Break2
- Detachment Of Device Component2
- Detachment of Device or Device Component1
- Material Fragmentation1
Patient problems
- Injury2
- No Clinical Signs, Symptoms or Conditions2
- No Code Available2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2023Fracture; Fracture
IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS A FRACTURED OASYS OCCIPITAL PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17430950 ↗MalfunctionMay 25, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
A COMPANY REPRESENTATIVE REPORTED THAT THE TULIP OF AN OASYS OCCIPUT PLATE ASSEMBLY FRACTURED POST-OPERATIVELY. NO ADVERSE CONSEQUENCES WERE REPORTED. REVISION SURGERY HAS NOT BEEN PERFORMED NOR SCHEDULED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17007472 ↗InjuryJan 25, 2018Break; Detachment Of Device Component; Fracture; Fracture
IT WAS REPORTED THAT THE TULIP HEADS BROKE OFF OF THE MEDIUM OCCIPITAL PLATE. A REPLACEMENT PLATE WAS IMPLANTED.
Patient problems: Injury; No Code Available
MAUDE report 7218063 ↗MalfunctionDec 28, 2017Break; Fracture; Material Fragmentation; Fracture
IT WAS REPORTED THAT; SURGEON WAS BENDING A PLATE, WHEN BENDING ON ONE OF THE LEGS IT SNAPPED. BENDING WITH BENDERS THAT COME WITH THE DEVICE. PERFORMED OVER THE PATIENT. ALL BROKEN FRAGMENTS RETRIEVED NO FRAGMENTS FELL INTO THE CAVITY. ANOTHER PLATE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY OR ADVERSE HEALTH CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7150881 ↗InjuryMar 8, 2016Fracture; Detachment Of Device Component; Fracture
IT WAS REPORTED THAT A TULIP HEAD ATTACHED TO A LEG OF THE PLATE DETACHED MAINTAINING ROD AND BLOCKER.
Patient problems: Injury; No Code Available
MAUDE report 5486597 ↗
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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