XIA II 03821545Recalls & reported problems
Stryker Corporation · POLYAXIAL SCREW · Class 2 · Implant
All models of XIA II (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540149183), received between Sep 21, 2016 and Jan 17, 2018 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break2
- Fracture2
- Detachment Of Device Component1
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient3
- Injury2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 17, 2018Detachment Of Device Component; Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT; PATIENT WAS PUT IN PRONE POSITION. THIS WAS A REGULAR OPERATION STERILIZATION SPREAD TOWELS, FULL CLEAR SURGICAL FIELD EXPOSURE, CONVENTIONAL CONE, OPEN OPEN DEVICE AGENT TAKE NAIL, NEEDLE, THE ESTABLISHMENT OF FLUOROSCOPY LOCATION IS GOOD, CHOOSE SCREW IMPLANT, POOR POSITION AFTER PERSPECTIVE. SURGEON REMOVED THE SCREW, FOUND THE SCREW DETACHED AND NEVER RECOVERED.
Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient
MAUDE report 7199493 ↗MalfunctionSep 21, 2016Break; Fracture; Fracture
IT WAS REPORTED THAT; SCREWS IMPLANTED IN 2007 BROKE ON BOTH SIDESADDLE S1 AT ABOUT THE SAME PLACE. THEY WERE 5.5 X 45. ALL HARDWARE WAS REMOVED AND NOTHING WAS REPLACED. PATIENT WAS FUSED AT L5 - S1.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 5966042 ↗InjurySep 21, 2016Break; Fracture; Fracture
IT WAS REPORTED THAT; SCREWS IMPLANTED IN 2007 BROKE ON BOTH SIDESADDLE S1 AT ABOUT THE SAME PLACE. THEY WERE 5.5 X45. ALL HARDWARE WAS REMOVED AND NOTHING WAS REPLACED. PATIENT WAS FUSED AT L5 - S1.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 5966017 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- 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 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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