XIA 3 4823718570Recalls & reported problems
Stryker Corporation · MEDIAL BIASED ANGLE POLYAXIAL SCREW · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252045847), received between Dec 19, 2018 and Dec 10, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Fall1
- Foreign Body In Patient1
- Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2021Migration; Migration
THE PATIENT WAS IMPLANTED WITH A XIA CONSTRUCT ON (B)(6) 2017. ON (B)(6) 2018, IT WAS REPORTED THAT THE TULIP OF A XIA 3 POLYAXIAL SCREW DISENGAGED AND THE RIGHT SIDE XIA II ROD FRACTURED AFTER THE PATIENT EXPERIENCED A FALL. ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT HAD BEEN REVISED ON 08 NOVEMBER 2021 TO ADDRESS THE PREVIOUSLY REPORTED DISENGAGED SCREW AND FRACTURED ROD, AS WELL AS A SECOND ROD FRACTURE (ON THE LEFT SIDE). DURING REVISION SURGERY, A XIA 3 POLYAXIAL SCREW WAS NOTED TO BE LOOSE, AND TWO XIA 3 MULTIAXIAL CROSSLINKS WERE REMOVED. EVALUATION OF THE RETURNED DEVICES IDENTIFIED THAT BOTH CROSSLINKS WERE FRACTURED. THIS RECORD CAPTURES THE LOOSE XIA 3 POLYAXIAL SCREW REMOVED DURING THE REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12977797 ↗InjuryDec 19, 2018Detachment of Device or Device Component
IT WAS REPORTED THAT THE SCREW HEAD HAS DETACHED INTRA OP, THE DETACHED SCREW WAS LEFT IN THE PATIENT WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. UPON 15 MONTHS ((B)(6) 2017) FOLLOW UP X-RAY REVIEW, THE COMPLETE SCREW HEAD DETACHMENT WAS CONFIRMED. FURTHER, THE PATIENT FELL IN (B)(6) 2018, CAUSING SCREW HEAD AND SHAFT TO DIVERGE.
Patient problems: Fall; Foreign Body In Patient; Injury; No Clinical Signs, Symptoms or Conditions
MAUDE report 8178467 ↗
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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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