XIA 4 5 48133230Recalls & reported problems
Stryker Corporation · 30-36 mm POLYAXIAL CROSS CONNECTOR · Class 2 · Implant
All models of XIA 4 5 (32)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540515087), received between Mar 17, 2016 and Aug 5, 2016 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Device Operates Differently Than Expected1
- Material Deformation1
- Material Integrity Problem1
- Mechanical Jam1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2016Device Operates Differently Than Expected; Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem
IT WAS REPORTED THAT; DURING SMALL SURGERY, THE SURGEON INSERTED THE SCREWS TO L5(CBT)-S. AND THE SURGEON TRIED TO USE THE CROSSLINK CONNECTOR(MEDIUM). BUT THE SURGEON COULD NOT ASSEMBLED THE CROSSLINK CONNECTOR. THEREFORE THE SURGEON TRIED TO REMOVE THE CROSSLINK CONNECTOR. WHEN THE SURGEON LOOSENED THE CENTER SCREW OF THE CONNECTOR, THE SCREW WAS DEFORMED. THEREFORE THE SURGEON REMOVED THE CROSSLINK CONNECTOR WITH THE ROD. AFTERWARDS, THE SURGEON USED THE LARGE CROSSLINK CONNECTOR. BUT, THE SURGEON COULD NOT ASSEMBLED THE CROSSLINK CONNECTOR. THEREFORE THE SURGEON NOT USED THE CROSSLINK CONNECTOR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5851670 ↗MalfunctionMar 17, 2016Mechanical Jam; Break; Mechanical Jam
IT WAS REPORTED THAT DURING THE SURGERY, THE SURGEON USED A CROSS CONNECTOR. THE SURGEON FORCED A DRIVER TIP INTO THE SCREW OF THE CROSS CONNECTOR USING A DRIVER, THE SCREW OF THE CROSS CONNECTOR BROKE. THE SURGEON CHANGED THE CROSS CONNECTOR TO ANOTHER SAME SIZE PRODUCT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5509219 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
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- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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 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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