OASYS 48561075Recalls & reported problems
Stryker Corporation · CROSS CONNECTOR NUT TIGHTENER · Class 1
All models of OASYS (60)
Data updated Oct 18, 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 07613327271577), received between Jun 30, 2017 and Aug 28, 2018 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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 18, 2026.
Most reported problems
Device problems
- Fracture3
- Break2
- Entrapment of Device1
- Material Fragmentation1
- Mechanical Jam1
Patient problems
- No Consequences Or Impact To Patient4
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2018Fracture; Material Fragmentation; Fracture
IT WAS REPORTED THAT ONE OF THE CASTLE TEETH FRAGMENTED OFF THE CROSS CONNECTOR NUT TIGHTENER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7825256 ↗MalfunctionJul 24, 2018Break; Fracture; Fracture
IT WAS REPORTED THAT THE CROSS NUT TIGHTENER BROKE AT THE TIP DURING FINAL TIGHTENING. THE BROKEN FRAGMENT WAS RETRIEVED. THERE ARE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7714449 ↗MalfunctionApr 30, 2018Mechanical Jam; Entrapment of Device; Mechanical Jam
IT WAS REPORTED THAT DURING INSTALLATION OF CONNECTOR AND TORQUE WRENCH, CONNECTION WAS LOOSE AND SURGEON WAS NOT ABLE TO PERFORM FINAL TIGHTENING. THE CONNECTOR COULD NOT BE REMOVED FROM THE TORQUE WRENCH. IT IS UNCLEAR HOW MUCH THE DOCTOR COULD TIGHTEN THE SCREW. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7474271 ↗MalfunctionJun 30, 2017Fracture; Break; Fracture
IT WAS REPORTED THAT; INSTRUMENT BROKE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6681580 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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