XIA 3 482335030Recalls & reported problems
Stryker Corporation · UNIPLANAR 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 07613327000993), received between May 23, 2017 and May 23, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Slipped” (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.
Most reported problems
Device problems
- Device Slipped2
- Mechanical Problem2
Patient problems
- No Known Impact Or Consequence To Patient2
- Arthritis1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2017Mechanical Problem; Device Slipped; Mechanical Problem
IT WAS REPORTED THAT; DURING REVISION SURGERY- WAS NOTED BY SURGEON THAT THERE WAS ROD SLIPPAGE. UPDATE 5/23/2017: THE REASON FOR THE REVISION SURGERY WAS DUE TO PSEUDARTHRITIS, NON FUSION. WHEN THE SURGEON WENT IN TO TREAT THE PSEUDARTHRITIS, THE ROD SLIPPAGE WAS NOTICED. PRIOR TO THE REVISION SURGERY, THERE WAS NO INDICATION/ISSUE NOTICED INVOLVING ANY OF THE PREVIOUS IMPLANTED PRODUCTS.
Patient problems: Arthritis; No Known Impact Or Consequence To Patient
MAUDE report 6586527 ↗MalfunctionMay 23, 2017Mechanical Problem; Device Slipped; Mechanical Problem
IT WAS REPORTED THAT; DURING REVISION SURGERY- WAS NOTED BY SURGEON THAT THERE WAS ROD SLIPPAGE. UPDATE 5/23/2017. THE REASON FOR THE REVISION SURGERY WAS DUE TO PSEUDARTHRITIS, NON FUSION. WHEN THE SURGEON WENT IN TO TREAT THE PSEUDARTHRITIS, THE ROD SLIPPAGE WAS NOTICED. PRIOR TO THE REVISION SURGERY, THERE WAS NO INDICATION/ISSUE NOTICED INVOLVING ANY OF THE PREVIOUS IMPLANTED PRODUCTS.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 6586506 ↗
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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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