OASYS 48552312Recalls & reported problems
Stryker Corporation · POLYAXIAL SCREW · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540371676), received between May 9, 2017 and May 9, 2017 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Deformation4
- Material Integrity Problem4
Patient problems
- No Known Impact Or Consequence To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2017Material Deformation; Material Integrity Problem; Material Deformation
IT WAS REPORTED THAT; SCREWS KEPT STRIPPING AS SOON AS ANY RESISTANCE WAS FELT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6553976 ↗MalfunctionMay 9, 2017Material Deformation; Material Integrity Problem; Material Deformation
IT WAS REPORTED THAT; SCREWS KEPT STRIPPING AS SOON AS ANY RESISTANCE WAS FELT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6553973 ↗MalfunctionMay 9, 2017Material Deformation; Material Integrity Problem; Material Deformation
IT WAS REPORTED THAT; SCREWS KEPT STRIPPING AS SOON AS ANY RESISTANCE WAS FELT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6553970 ↗MalfunctionMay 9, 2017Material Deformation; Material Integrity Problem; Material Deformation
IT WAS REPORTED THAT; SCREWS KEPT STRIPPING AS SOON AS ANY RESISTANCE WAS FELT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6553868 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
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- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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