XIA II 03821540Recalls & reported problems
Stryker Corporation · POLYAXIAL SCREW · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540149176), received between Apr 28, 2017 and Apr 4, 2018 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Fracture4
- Material Integrity Problem3
- Detachment Of Device Component1
- Disconnection1
Patient problems
- Pain4
- Injury2
- No Information2
- Failure of Implant1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2018Disconnection; Break; Detachment Of Device Component; Disconnection
IT WAS REPORTED THAT THE TULIP/ BLADES BROKE OFF THE SCREW THREAD AFTER FINAL TIGHTENING. A NEW SCREW WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A TOTAL SURGICAL DELAY OF 20 TO 30 MINUTES. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7395061 ↗InjuryMar 28, 2018Fracture; Break; Fracture
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015. FOLLOWING SURGERY, THE PATIENT EXPERIENCED PAIN. IT WAS VERIFIED THAT A SCREW BROKE POST OPERATIVELY AND ANOTHER REVISION SURGERY WOULD BE NECESSARY. REVISION SURGERY HAS NOT BEEN PERFORMED AT THIS TIME.
Patient problems: Failure of Implant; Injury; Pain
MAUDE report 7379267 ↗MalfunctionOct 25, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
InjuryOct 25, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
InjuryApr 28, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT; AFTER FIVE MONTHS OF INITIAL SURGERY, THE PATIENT RELATED PAIN TO SURGEON. THE SCREW WAS BROKEN AND A NEW PROCEDURE WAS SCHEDULED TO REPLACE IT.
Patient problems: Injury; Pain
MAUDE report 6530322 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
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- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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 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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