XIA II 03828645Recalls & reported problems
Stryker Corporation · MONOAXIAL REDUCTION SCREW · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613154407644), received between Nov 25, 2019 and Jun 9, 2020 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
Patient problems
- Injury3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2020Fracture; Fracture
IT WAS REPORTED THAT TWO XIA DEFORMITY LONG ARM MONOAXIAL SCREWS FRACTURED POST-OPERATIVELY. RADIOGRAPHY SHOWED THAT THE TWO SCREWS HAD FRACTURED AND THAT THE PATIENT HAD FUSED. REVISION SURGERY WAS PERFORMED AND THE TWO SCREWS WERE SUCCESSFULLY REMOVED. THIS REPORT REPRESENTS THE FIRST OF THE TWO SCREWS.
Patient problems: Injury
MAUDE report 10136034 ↗InjuryJun 9, 2020Fracture; Fracture
IT WAS REPORTED THAT TWO XIA DEFORMITY LONG ARM MONOAXIAL SCREWS FRACTURED POST-OPERATIVELY. RADIOGRAPHY SHOWED THAT THE TWO SCREWS HAD FRACTURED AND THAT THE PATIENT HAD FUSED. REVISION SURGERY WAS PERFORMED AND THE TWO SCREWS WERE SUCCESSFULLY REMOVED. THIS REPORT REPRESENTS THE SECOND OF THE TWO SCREWS.
Patient problems: Injury
MAUDE report 10136032 ↗MalfunctionJan 3, 2020Fracture; Fracture
IT WAS REPORTED THAT A XIA DEFORMITY REDUCTION LONG ARM MONOXIAL SCREW AND A MANTIS LONG CONSTRUCT HEX STRAIGHT ROD WAS FOUND FRACTURED DURING SCREW AND ROD REMOVAL POST-OPERATIVELY. THIS RECORD REPRESENTS THE SCREW.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9547824 ↗InjuryNov 25, 2019Fracture; Fracture
A PHYSICIAN REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS A BROKEN XIA DEFORMITY REDUCTION LONG ARM MONOAXIAL SCREW. THE SCREW WAS NOTED TO BE IMPLANTED VERY DEEP AND IT WAS DETERMINED THAT REMOVING IT WOULD CAUSE HARM TO THE PATIENT. THEREFORE, THE SCREW WAS LEFT IMPLANTED IN THE PATIENT'S BONE.
Patient problems: Injury
MAUDE report 9372080 ↗
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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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