OASYS 48558312Recalls & reported problems
Stryker Corporation · NON-BIASED POLYAXIAL SCREW · Class 2 · Implant
All models of OASYS (60)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540596314), received between Dec 21, 2016 and Nov 8, 2017 — classified as 2 injuries.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Disassembly1
- Disconnection1
- Mechanical Jam1
Patient problems
- Failure of Implant1
- Injury1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 8, 2017Disassembly; Disconnection; Disconnection
IT WAS REPORTED THAT; DOCTOR HAD TO REMOVE POST CERVICAL SCREW RIGHT C3 LATERAL MASS SCREW. AFTER LOOKING AT XRAYS THE IMAGES REVEALED THAT THE ROD AND SCREW DISASSOCIATED. DOCTOR REMOVED SET SCREW AND THEN REMOVED THE LATERAL MASS SCREW. WHILE ATTEMPTING TO REMOVE THE TULIP POPPED OFF OF THE SHAFT. DOCTOR THEN USED INSTRUMENT TO BACK OUT SHAFT AND CUT THE ROD ABOVE RIGHT C4 SCREW. DOCTOR CHECKED OTHER SCREWS TO CONFIRM SET SCREWS WERE TIGHTENED SUFFICIENTLY. THIS WAS NOTICED BY SURGEON'S PA, THE PATIENT WAS COMPLAINING OF SQUEAKING SOUNDS IN NECK. THIS WAS FROM A PRIOR SURGERY DATE IS UNKNOWN, THOUGHT IT WAS END (B)(6) 2017.
Patient problems: Failure of Implant; Injury
MAUDE report 7008938 ↗InjuryDec 21, 2016Mechanical Jam; Difficult to Remove; Mechanical Jam
IT WAS REPORTED THAT A SCREW ON THE LEFT AT C5 HAD TO BE REMOVED, AFTER REMOVING BLOCKER AND GETTING ROD OUT OF THE WAY, THE SURGEON WAS UNABLE TO ACCESS THE SCREW HEAD DUE TO IT BEING COLD FUSED. ROCKED SCREW BACK AND FORTH TOO MUCH, THEN USED AN ALTERNATIVE INSTRUMENT AND PULLED SCREW OUT. THIS WAS NOT IDEAL AND SURGEON REQUESTED I SEND SCREW IN TO BE ANALYZED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6196350 ↗
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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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