XIA 3 482378580Recalls & reported problems
Stryker Corporation · CLOSED HEAD POLYAXIAL SCREW · Class 2 · Implant
All models of XIA 3 (93)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327001198), received between May 24, 2017 and May 24, 2017 — classified as 1 malfunction.
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
- Detachment Of Device Component1
- Loose or Intermittent Connection1
- Mechanical Problem1
Patient problems
- Failure of Implant1
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 24, 2017Break; Detachment Of Device Component; Loose or Intermittent Connection; Mechanical Problem; Detachment Of Device Component; Mechanical Problem
IT WAS REPORTED THAT: PRIMARY SURGERY FOR SCOLIOSIS WAS PERFORMED ON (B)(6) 2011 AND L1-5 WERE FIXED WITH. AFTER THAT, THE FIXATION WAS EXTENDED TO ILIAC AND THE RODS WERE ADDED BECAUSE THE SCOLIOSIS HAD PROGRESSED ON (B)(6) 2012. THEN, THE ROD BREAKAGE AT L3/4 WAS FOUND AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2017. IN THE REVISION SURGERY, PSO OF L3 WAS PERFORMED. THE SCREWS WERE REMAINED, THE BLOCKERS AND RODS WERE REPLACED TO NEW ARTICLES. AT THAT TIME, THE LOOSENING OF THE BLOCKERS OF THE ILIAC SCREWS WERE CONFIRMED.
Patient problems: Failure of Implant; Injury
MAUDE report 6589700 ↗
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- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
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- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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