XIA 4 5Recalls & reported problems across all models
Stryker Corporation · 32 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 105
- Deaths reported
- 0
- Injuries reported
- 68
- Recalls
- 0
We found 32 models of XIA 4 5 by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 105 adverse event reports in the FDA's MAUDE database, received between Feb 16, 2016 and Dec 15, 2025 — classified as 68 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Fracture” (36 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported XIA 4 5 problems
Device problems
- Fracture36
- Migration31
- Break27
- Mechanical Problem15
- Device Dislodged or Dislocated14
- Migration or Expulsion of Device11
- Device Slipped10
- Material Integrity Problem10
Patient problems
- Injury53
- No Known Impact Or Consequence To Patient33
- No Clinical Signs, Symptoms or Conditions21
- No Code Available14
- Pain14
- No Consequences Or Impact To Patient12
- No Information6
- Fall4
XIA 4 5 models
32 models, most reported first. Each model has its own page with its reports, recalls and device details.
- XIA 4 5 48130000Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48135104Orthosis, spinal pedicle fixation, for degenerative disc disease9 reports
- XIA 4 5 48135103Orthosis, spondylolisthesis spinal fixation8 reports
- XIA 4 5 48132601ORTHOSIS, SPINAL PEDICLE FIXATION8 reports
- XIA 4 5 48133236Orthosis, spondylolisthesis spinal fixation5 reports
- XIA 4 5 48133480APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- XIA 4 5 48144035Orthosis, spondylolisthesis spinal fixation4 reports
- XIA 4 5 481322070ORTHOSIS, SPINAL PEDICLE FIXATION4 reports
- XIA 4 5 481322040Orthosis, spinal pedicle fixation, for degenerative disc disease3 reports
- XIA 4 5 48133200APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- XIA 4 5 48146535APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- XIA 4 5 48133230ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- XIA 4 5 48133245APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- XIA 4 5 48135005Orthosis, spondylolisthesis spinal fixation2 reports
- XIA 4 5 481321040Orthosis, spinal pedicle fixation, for degenerative disc disease2 reports
- XIA 4 5 481322120ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- XIA 4 5 481321120APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- XIA 4 5 48133024APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- XIA 4 5 48144530ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- XIA 4 5 48145525APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- XIA 4 5 48145540APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- XIA 4 5 48145550Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- XIA 4 5 48146545ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- XIA 4 5 48146550APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- XIA 4 5 48146560APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- XIA 4 5 48146570ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- XIA 4 5 48133224Orthosis, spondylolisthesis spinal fixation1 report
- XIA 4 5 48145555Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- XIA 4 5 481321060APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- XIA 4 5 481322050ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- XIA 4 5 481322060APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- XIA 4.5 48130100INSTRUMENT, SURGICAL, NON-POWERED1 report
Recent XIA 4 5 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 15, 2025Migration; Migration
A HEALTH PROFESSIONAL REPORTED THAT FOUR XIA 4.5 POLYAXIAL SCREWS AND FOUR XIA 4.5 BLOCKERS MIGRATED POST-OPERATIVELY. THE PATIENT WAS REVISED APPROXIMATELY ONE MONTH POST-OPERATIVELY. THIS REPORT CAPTURES THE FOURTH OF FOUR BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23812753 ↗InjuryDec 15, 2025Migration; Migration
A HEALTH PROFESSIONAL REPORTED THAT FOUR XIA 4.5 POLYAXIAL SCREWS AND FOUR XIA 4.5 BLOCKERS MIGRATED POST-OPERATIVELY. THE PATIENT WAS REVISED APPROXIMATELY ONE MONTH POST-OPERATIVELY. THIS REPORT CAPTURES THE SECOND OF FOUR BLOCKERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23812720 ↗InjuryDec 15, 2025Migration; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23812719 ↗InjuryDec 15, 2025Migration; Migration
A HEALTH PROFESSIONAL REPORTED THAT FOUR XIA 4.5 POLYAXIAL SCREWS AND FOUR XIA 4.5 BLOCKERS MIGRATED POST-OPERATIVELY. THE PATIENT WAS REVISED APPROXIMATELY ONE MONTH POST-OPERATIVELY. THIS REPORT CAPTURES THE THIRD OF FOUR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23812692 ↗InjuryDec 15, 2025Migration; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23812691 ↗InjuryDec 15, 2025Migration; Migration
A HEALTH PROFESSIONAL REPORTED THAT FOUR XIA 4.5 POLYAXIAL SCREWS AND FOUR XIA 4.5 BLOCKERS MIGRATED POST-OPERATIVELY. THE PATIENT WAS REVISED APPROXIMATELY ONE MONTH POST-OPERATIVELY. THIS REPORT CAPTURES THE FOURTH OF FOUR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23812690 ↗InjuryDec 15, 2025Migration; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23812687 ↗InjuryDec 15, 2025Migration; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23812683 ↗InjuryFeb 13, 2023Migration; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS A MIGRATED XIA 4.5 BLOCKER AND XIA 4.5 POLYAXIAL SCREW APPROXIMATELY 3.5 MONTHS AFTER IMPLANTATION. THIS REPORT IS FOR THE XIA 4.5 BLOCKER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16369167 ↗MalfunctionMar 4, 2022Migration; Migration
A PHYSICIAN REPORTED THAT A XIA 4.5 TITANIUM BLOCKER AT S2 ON THE RIGHT SIDE HAS LOOSENED AND THE ROD, "IS ABOUT TO COME OFF." REVISION SURGERY HAS NOT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13667409 ↗InjuryFeb 3, 2022Fracture; Fracture
A PATIENT WAS REVISED AFTER TWO XIA 4.5 TITANIUM EXTENDED CONNECTORS FRACTURED. THIS REPORT CAPTURES THE FIRST OF TWO CONNECTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13446895 ↗InjuryFeb 3, 2022Fracture; Fracture
A PATIENT WAS REVISED AFTER TWO XIA 4.5 TITANIUM EXTENDED CONNECTORS FRACTURED. THIS REPORT CAPTURES THE SECOND OF TWO CONNECTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13446892 ↗InjuryFeb 3, 2022Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY 4 YEARS POST-OPERATIVELY A XIA 4.5 TITANIUM CONNECTOR BROKE. REVISION SURGERY WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13446816 ↗InjuryNov 24, 2021Fracture; Fracture
IT WAS REPORTED THAT TWO XIA TITANIUM 4.5 VITALIUM RODS FRACTURED APPROXIMATELY TWO YEARS POST-OPERATIVELY. THE PATIENT HAS BEEN REVISED. THIS RECORD CAPTURES THE FIRST OF THE TWO FRACTURED XIA 4.5 RODS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12868377 ↗InjuryNov 24, 2021Fracture; Fracture
IT WAS REPORTED THAT TWO XIA TITANIUM 4.5 VITALIUM RODS FRACTURED APPROXIMATELY TWO YEARS POST-OPERATIVELY. THE PATIENT HAS BEEN REVISED. THIS RECORD CAPTURES THE SECOND OF THE TWO FRACTURED XIA 4.5 RODS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12868371 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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