XIA 4.5 System - XIA CT 488515535Recalls & reported problems
Stryker Corporation · Polyaxial Cortical Screw · Class 2 · Implant
All models of XIA 4.5 System - XIA CT (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327137347), received between May 2, 2019 and Jun 5, 2020 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (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 18, 2026.
Most reported problems
Device problems
- Unintended Movement2
- Detachment of Device or Device Component1
- Fracture1
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient2
- Injury1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2020Fracture; Fracture
IT WAS REPORTED THAT A TRITANIUM PL CAGE AND A XIA CT POLYAXIAL CORTICAL SCREW, IMPLANTED AT L5-S1, FRACTURED POST-OPERATIVELY. FUSION WAS NOT ACHIEVED. REVISION SURGERY WILL OCCUR TO REPLACE DEVICES. THIS REPORT CAPTURES THE SCREW.
Patient problems: Injury
MAUDE report 10125323 ↗MalfunctionMay 2, 2019Detachment of Device or Device Component; Unintended Movement; Unintended Movement
THE SURGEON REPORTED THAT DURING A PRE-SCHEDULED FUSION EXTENSION SURGERY, THE TULIP HEAD OF BOTH THE RIGHT AND LEFT SIDE L5 SCREW WAS NOT ATTACHED TO THE SHAFT. PATIENTS PREVIOUS SURGERY WAS DONE PRIOR TO DECEMBER OF 2016. NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8573236 ↗MalfunctionMay 2, 2019Material Separation; Unintended Movement; Unintended Movement
THE SURGEON REPORTED THAT DURING A PRE-SCHEDULED FUSION EXTENSION SURGERY, THE TULIP HEAD OF THE RIGHT AND LEFT L5 SCREW WAS NOT ATTACHED TO THE SHAFT. PATIENTS PREVIOUS SURGERY WAS DONE PRIOR TO DECEMBER OF 2016. NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8573165 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
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- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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