OASYSRecalls & reported problems across all models
Stryker Corporation · 60 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 224
- Deaths reported
- 0
- Injuries reported
- 63
- Recalls
- 0
We found 60 models of OASYS by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 224 adverse event reports in the FDA's MAUDE database, received between Feb 12, 2016 and Mar 5, 2026 — classified as 63 injuries, 161 malfunctions.
The most frequently reported specific device problem is “Break” (76 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported OASYS problems
Device problems
- Break76
- Fracture66
- Migration37
- Device Dislodged or Dislocated31
- Mechanical Problem30
- Detachment Of Device Component29
- Detachment of Device or Device Component26
- Material Integrity Problem24
Patient problems
- No Known Impact Or Consequence To Patient110
- No Clinical Signs, Symptoms or Conditions47
- Injury43
- No Consequences Or Impact To Patient30
- No Code Available11
- Failure of Implant7
- No Information6
- Device Embedded In Tissue or Plaque5
OASYS models
60 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OASYS 48551000Orthosis, cervical pedicle screw spinal fixation45 reports
- OASYS 48558528APPLIANCE, FIXATION, SPINAL INTERLAMINAL16 reports
- OASYS 48551070APPLIANCE, FIXATION, SPINAL INTERLAMINAL14 reports
- OASYS 48552314APPLIANCE, FIXATION, SPINAL INTERLAMINAL9 reports
- OASYS 48558524APPLIANCE, FIXATION, SPINAL INTERLAMINAL8 reports
- OASYS 48555424Orthosis, cervical pedicle screw spinal fixation7 reports
- OASYS 48558532Orthosis, cervical pedicle screw spinal fixation7 reports
- OASYS 48561051ORTHOPEDIC MANUAL SURGICAL INSTRUMENT7 reports
- OASYS 48552322APPLIANCE, FIXATION, SPINAL INTERLAMINAL5 reports
- OASYS 48551044Orthosis, cervical pedicle screw spinal fixation5 reports
- OASYS 48551045Orthosis, cervical pedicle screw spinal fixation5 reports
- OASYS 48552312APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- OASYS 48552324APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- OASYS 48552326APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- OASYS 48555324APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- OASYS 48556328APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- OASYS 48561075ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- OASYS 48562018ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- OASYS 48552240APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- OASYS 48552426Orthosis, cervical pedicle screw spinal fixation3 reports
- OASYS 48552430APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- OASYS 48551071APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- OASYS 48558520Orthosis, cervical pedicle screw spinal fixation3 reports
- OASYS 48558536APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- OASYS 48552330Orthosis, cervical pedicle screw spinal fixation3 reports
- OASYS 48556326APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- OASYS 48552318APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- OASYS 48552442APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- OASYS 48551072APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- OASYS 48557314Orthosis, cervical pedicle screw spinal fixation2 reports
- OASYS 48558312APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- OASYS 48553240APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- OASYS IS3107OASORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- OASYS 48560022ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- OASYS 48561024ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- OASYS 48560028ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- OASYS 48552080Orthosis, cervical pedicle screw spinal fixation1 report
- OASYS 48552120Orthosis, cervical pedicle screw spinal fixation1 report
- OASYS 48552316Orthosis, cervical pedicle screw spinal fixation1 report
- OASYS 48552424APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- OASYS 48552438Orthosis, cervical pedicle screw spinal fixation1 report
- OASYS 48554308Orthosis, cervical pedicle screw spinal fixation1 report
- OASYS 48554318APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- OASYS 48552428Orthosis, cervical pedicle screw spinal fixation1 report
- OASYS 48555322APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- OASYS 48555328Orthosis, cervical pedicle screw spinal fixation1 report
- OASYS 48555332APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- OASYS 48555420Orthosis, cervical pedicle screw spinal fixation1 report
- OASYS 48556322APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- OASYS 48556332APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- OASYS 48558320APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- OASYS 48551046APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- OASYS 48551048APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- OASYS 48552334Orthosis, cervical pedicle screw spinal fixation1 report
- OASYS 48552332APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- OASYS 48553608APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- OASYS 48561039INSTRUMENT, SURGICAL, NON-POWERED1 report
- OASYS 48561914ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- OASYS 48562011ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- OASYS 48565323ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent OASYS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 5, 2026Fracture
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS A FRACTURED OASYS ROD.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24526880 ↗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 ↗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 ↗MalfunctionDec 17, 2025Difficult to Insert; Difficult to Insert
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23828916 ↗MalfunctionDec 17, 2025Difficult to Insert; Difficult to Insert
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23828914 ↗MalfunctionJul 16, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF AN OASYS POLYAXIAL SCREWDRIVER WAS DEFORMED AND DIFFICULT TO ENGAGE WITH A SCREW TULIP INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22522536 ↗MalfunctionJun 10, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF AN OASYS POLYAXIAL SCREWDRIVER WAS DEFORMED AND DIFFICULT TO ENGAGE WITH A SCREW TULIP INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22177639 ↗InjuryMay 30, 2025Migration; Migration
THE PATIENT WAS REPORTED TO HAVE RHEUMATISM AND POOR BONE QUALITY.
Patient problems: Paresis; Spinal Column Injury
MAUDE report 22116657 ↗MalfunctionApr 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21939289 ↗MalfunctionApr 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE TULIPS OF TWO OASYS POLYAXIAL SCREWS DISENGAGED INTRA-OPERATIVELY WHILE REMOVING THE SCREWS AND THAT THE SCREW SHANKS REMAIN IMPLANTED IN THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21939283 ↗MalfunctionMar 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21549409 ↗MalfunctionMar 3, 2025Difficult to Insert; Detachment of Device or Device Component; Device Dislodged or Dislocated; Difficult to Insert; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT FOUR OASYS POLYAXIAL SCREWS WERE DIFFICULT TO INSERT AND THAT THE TULIPS OF ALL FOUR SCREWS DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWO HOUR SURGICAL DELAY. THIS REPORT CAPTURES THE THIRD OF FOUR OASYS SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21510797 ↗MalfunctionMar 3, 2025Difficult to Insert; Detachment of Device or Device Component; Device Dislodged or Dislocated; Difficult to Insert; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT FOUR OASYS POLYAXIAL SCREWS WERE DIFFICULT TO INSERT AND THAT THE TULIPS OF ALL FOUR SCREWS DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWO HOUR SURGICAL DELAY. THIS REPORT CAPTURES THE FOURTH OF FOUR OASYS SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21510794 ↗MalfunctionMar 3, 2025Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component
IT WAS REPORTED THAT FOUR OASYS POLYAXIAL SCREWS WERE DIFFICULT TO INSERT AND THAT THE TULIPS OF ALL FOUR SCREWS DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWO HOUR SURGICAL DELAY. THIS REPORT CAPTURES THE FIRST OF FOUR OASYS SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21510701 ↗MalfunctionMar 3, 2025Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component
IT WAS REPORTED THAT FOUR OASYS POLYAXIAL SCREWS WERE DIFFICULT TO INSERT AND THAT THE TULIPS OF ALL FOUR SCREWS DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWO HOUR SURGICAL DELAY. THIS REPORT CAPTURES THE SECOND OF FOUR OASYS SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21510698 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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