XIA 4 5 48135005Recalls & reported problems
Stryker Corporation · Dia. 4.5 - Dia. 4.5 SMALL PARALLEL ROD TO ROD CONNECTOR · Class 2 · Implant
All models of XIA 4 5 (32)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540649331), received between Sep 28, 2016 and Mar 1, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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
- Insufficient Device Problem Information1
- Material Deformation1
- Mechanical Jam1
- Mechanical Problem1
Patient problems
- Injury1
- 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.
InjuryMar 1, 2017Mechanical Problem; Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT; INITIAL PROCEDURE DID FOR SCOLIOSIS ON (B)(6) 2012. ADDITIONAL PROCEDURE DID ON (B)(6) 2017. DIFFICULT TO BE LOOSED A CONNECTOR OF THE LOD BY THE BLOCKER. SO OPENED(EXPANDED) ALL OF CRANIAL SIDE ADDITIONALLY AND REMOVED SOME SCREWS, THEN REMOVED ROD AND BLOCKER TOGETHER.
Patient problems: Injury; No Code Available
MAUDE report 6370591 ↗MalfunctionSep 28, 2016Insufficient Device Problem Information; Material Deformation; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SURGERY WITHOUT FUSION. ON (B)(6) 2016, THE PATIENT UNDERWENT THE SURGERY OF THE ROD EXTENSION. WHEN THE SURGEON TRIED LOOSENED THE SET SCREW OF THE CONNECTOR, THE SET SCREW DEFORMED. THEREFORE THE SURGEON CHANGED THE EXTENSION PART TO ANOTHER PART.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5983311 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
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- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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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