XIA 4 5 481322120Recalls & reported problems
Stryker Corporation · VITALLIUM PREBENT AND PRECUT ROD WITHOUT HEX · Class 2 · Implant
All models of XIA 4 5 (32)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327002669), received between Jun 27, 2018 and Jun 27, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Migration2
Patient problems
- Injury2
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2018Device Dislodged or Dislocated; Migration; Migration
IT WAS REPORTED THAT AFTER AN L2-S1 FUSION, THE ROD DISLODGED FROM THE L2 SCREWS BILATERALLY RESULTING IN THE PATIENT'S SECOND REVISION SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPOSITIONING THE CAGE WITH NEW RODS AND BLOCKERS. ADVERSE REACTIONS TO THE PATIENT INCLUDED REVISION SURGERY AS IT REQUIRED MEDICAL INTERVENTION.
Patient problems: Injury; No Code Available
MAUDE report 7643349 ↗InjuryJun 27, 2018Device Dislodged or Dislocated; Migration; Migration
IT WAS REPORTED THAT AFTER AN L2-S1 FUSION, THE ROD DISLODGED FROM THE L2 SCREWS BILATERALLY RESULTING IN THE PATIENT'S SECOND REVISION SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPOSITIONING THE CAGE WITH NEW RODS AND BLOCKERS. ADVERSE REACTIONS TO THE PATIENT INCLUDED REVISION SURGERY AS IT REQUIRED MEDICAL INTERVENTION.
Patient problems: Injury; No Known Impact Or Consequence To Patient
MAUDE report 7643348 ↗
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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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