XIA 3 482365535Recalls & reported problems
Stryker Corporation · UNIPLANAR REDUCTION SCREW · Class 2 · Implant
Data updated Oct 13, 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 07613327000900), received between Jun 27, 2018 and Jan 16, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Material Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- 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.
MalfunctionJan 16, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A REVISION SURGERY TO ADDRESS DISTAL JUNCTION KYPHOSIS, THE SURGEON NOTED TULIP DISENGAGEMENTS OF THREE OF THE PREVIOUSLY IMPLANTED XIA UNIPLANAR REDUCTION SCREWS. THE SCREWS WERE EXPLANTED AND REPLACED. THIS REPORT CAPTURES THE SECOND OF THREE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18519803 ↗MalfunctionJun 27, 2018Material Separation; Detachment of Device or Device Component; Detachment of Device or Device Component
DURING A PSO AND VCR SURGERY, THREE DISTAL SCREWS WERE TIGHTENED AND ONE PROXIMAL SCREW. WHILE COMPRESSING AND TIGHTENING THE SCREW IN QUESTION, THE TULIP AND SCREW SHAFT SEPARATED. THE SURGERY WAS COMPLETED SUCCESSFULLY USING AN ALTERNATE SCREW. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7643355 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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