XIA II 03802480Recalls & reported problems
Stryker Corporation · CP TITANIUM STRAIGHT ROD · Class 2 · Implant
All models of XIA II (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540147905), received between Oct 2, 2018 and Sep 1, 2021 — classified as 5 injuries.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fracture5
- Break3
Patient problems
- Injury4
- Pain3
- No Code Available1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 1, 2021Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED PAIN AND IMAGING REVEALED A FRACTURED XIA LP POLYAXIAL SCREW, A FRACTURED XIA ROD, AND A XIA 3 TITANIUM POLYAXIAL SCREW WITH "HEAD PULL OUT." THE PATIENT UNDERWENT REVISION SURGERY. THE BODY OF THE XIA 3 TITANIUM POLYAXIAL SCREW WAS NOT ABLE TO BE REMOVED AND REMAINS IMPLANTED IN THE PATIENT'S ILLIUM. THIS REPORT CAPTURES THE FRACTURED XIA II ROD.
Patient problems: Pain
MAUDE report 12407887 ↗InjuryFeb 14, 2020Fracture; Fracture
IT WAS REPORTED THAT A XIA 2 ROD FRACTURED POST-OPERATIVELY. THE PATIENT WAS NOTED TO HAVE ALREADY ACHIEVED FUSION. REVISION SURGERY WAS PERFORMED TO REMOVE THE FRACTURED ROD.
Patient problems: Injury
MAUDE report 9711543 ↗InjuryNov 12, 2018Fracture; Break; Fracture
IT WAS REPORTED THAT THE ROD BROKE POST-OPERATIVELY. THE MEDICAL INTERVENTION REQUIRED TO REMOVE THE SCREW AND ROD.
Patient problems: Injury; No Code Available
MAUDE report 8061435 ↗InjuryOct 2, 2018Break; Fracture; Fracture
IT WAS REPORTED THAT A PATIENT WAS OPERATED ON (B)(6) 2015 WITH DIAGNOSIS OF SPINE SCOLIOSIS. AFTER AN ABRUPT INCLINATION, THE PATIENT FELT A SHARP PAIN IN LOWER BACK. DURING FURTHER EXAMINATION A BREAKAGE OF 2 RODS WAS FOUND. PATIENT WENT TROUGH A REVISION SURGERY ON (B)(6) 2018 AND WAS DISCHARGED FROM THE HOSPITAL IN A SATISFACTORY CONDITION.
Patient problems: Injury; Pain
MAUDE report 7928148 ↗InjuryOct 2, 2018Break; Fracture; Fracture
IT WAS REPORTED THAT A PATIENT WAS OPERATED ON (B)(6) 2015 WITH DIAGNOSIS OF SPINE SCOLIOSIS. AFTER AN ABRUPT INCLINATION, THE PATIENT FELT A SHARP PAIN IN LOWER BACK. DURING FURTHER EXAMINATION A BREAKAGE OF 2 RODS WAS FOUND. PATIENT WENT TROUGH A REVISION SURGERY ON (B)(6) 2018 AND WAS DISCHARGED FROM THE HOSPITAL IN A SATISFACTORY CONDITION.
Patient problems: Injury; Pain
MAUDE report 7928147 ↗
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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