OASYS 48552332Recalls & reported problems
Stryker Corporation · POLYAXIAL SCREW · Class 2 · Implant
All models of OASYS (60)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154129874), received between Apr 27, 2017 and Apr 27, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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
- Device Dislodged or Dislocated1
- Material Separation1
- Mechanical Problem1
Patient problems
- Failure of Implant1
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2017Mechanical Problem; Material Separation; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated
IT WAS REPORTED THAT; THERE WERE SEPARATION (HEAD AND SCREW) OF POLYAXIAL SCREW 2 TIMES AFTER SCREW IMPLANT OPERATION. SCREWS WERE OPERATED FIXATION TO CERVICAL 1 AND 2 ON (B)(6). THERE WAS NO ABNORMAL DURING ROUTINE X-RAY CHECK-UP. ONE MONTH LATER, BREAKAWAY OF THE SCREW FROM ITS HEAD WAS DETECTED ON X-RAY AMONG ONE OF IMPLANTED POLYAXIAL SCREW TO C1. SO 2ND OPERATION WAS CONDUCTED (REMOVE DEFEAT PART AND FIX NEW ONE), THEN ANOTHER BREAKAWAY WAS FOUND FOR IMPLANTED SCREW TO C2 DURING ROUTINE X-RAY CHECK-UP. NEXT DAY, 3RD OPERATION WAS CONDUCTED (REMOVED DEFEAT PART AND FIX NEW ONE).
Patient problems: Failure of Implant; Injury
MAUDE report 6525461 ↗
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- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
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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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