OASYS 48556326Recalls & reported problems
Stryker Corporation · SMOOTH SHANK 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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327067606), received between Apr 1, 2019 and May 19, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (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
- Break2
- Material Integrity Problem2
- Material Separation1
Patient problems
- Failure of Implant2
- Injury2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2023Material Separation; Material Separation
IT WAS REPORTED THAT 4 DAYS POST-OPERATIVELY THE HEAD OF AN OASYS SMOOTH SHANK POLYAXIAL SCREW HAD SEPARATED FROM THE SHANK. THE SCREW WAS REMOVED DURING A REVISION SURGERY WHICH LASTED 3 HOURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16968677 ↗InjuryApr 1, 2019Break; Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SCREW WAS BROKEN POST-OPERATIVELY. THE PATIENT UNDERWENT REVISION SURGERY.
Patient problems: Failure of Implant; Injury
MAUDE report 8471120 ↗InjuryApr 1, 2019Break; Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SCREW WAS BROKEN POST-OPERATIVELY. THE PATIENT UNDERWENT REVISION SURGERY.
Patient problems: Failure of Implant; Injury
MAUDE report 8471113 ↗
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- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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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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