XIA 3 482319550Recalls & reported problems
Stryker Corporation · 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 04546540598691), received between Apr 26, 2017 and Apr 26, 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
- Difficult to Remove1
- Mechanical Problem1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2017Break; Detachment Of Device Component; Mechanical Problem; Difficult to Remove; Detachment Of Device Component; Mechanical Problem
IT WAS REPORTED THAT; DR. PLACED 9.5X50 SCREW IN LEFT S1 PEDICLE DURING REVISION SURGERY. DR WAS REPLACING CURRENT 8.5 DIAMETER SCREW WITH LARGER DUE TO HAVING A 'LOOSE FEEL'. UPON PLACEMENT, DR WANTED TO REMOVED AND REDIRECT DUE TO 'POOR' TRAJECTORY, BUT COULD NOT. DR. BROKE HANDLE/DRIVER/NUT TRYING TO REMOVE WITH PRIMARY DRIVER, THEN SWITCH TO LUMBAR REMOVAL DRIVER OVER A LOCKED DOWN PIECE OF ROD WITH BLOCKER TO TOP OF TULIP TO TRY TO 'HELICOPTER' SCREW OUT SINCE IT WAS SO STUCK. DURING PROCESS OF TRYING TO REMOVE, HE BROKETULIP/ HEAD OFF OF SCREW OFF OF MAIN SCREW SHAFT. DR COULD NOT REMOVE REMAINDER OF BROKEN SCREW FROM PATIENT WITH LUMBAR REMOVAL SET - SO HE LEFT IT IN PLACE DUE TO NOT HAVING EFFECT PM PATIENT'S OUTCOME AND MOVED ON WITH CASE.
Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient
MAUDE report 6524684 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
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- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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