XIA 4 5 48146535Recalls & reported problems
Stryker Corporation · POLYAXIAL SCREW · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540450258), received between Dec 6, 2018 and Dec 6, 2018 — classified as 2 injuries.
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
- Migration2
- Detachment of Device or Device Component1
Patient problems
- Ambulation or Postural Difficulties2
- Dyspnea2
- Fall2
- Injury2
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2018Migration; Break; Migration
IT WAS REPORTED THAT THE ROD BROKE IN HALF AND SCREWS CAME OUT POST-OPERATIVELY. PATIENT REPORTEDLY HAD FALL IN (B)(6) 2017 IN WHICH SHE TRIPPED OVER A CHAIR AND FELL ON THEIR KNEES. THE PATIENT WAS IN PAIN, COULDN'T WALK, TROUBLE BREATHING AND COULDN'T LIFT ARM. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 TO REPLACE HARDWARE.
Patient problems: Ambulation or Postural Difficulties; Dyspnea; Fall; Injury; Pain
MAUDE report 8139738 ↗InjuryDec 6, 2018Migration; Break; Detachment of Device or Device Component; Migration
IT WAS REPORTED THAT THE ROD BROKE IN HALF AND SCREWS CAME OUT POST-OPERATIVELY. PATIENT REPORTEDLY HAD FALL IN (B)(6) OF 2017 IN WHICH SHE TRIPPED OVER A CHAIR AND FELL ON THEIR KNEES. THE PATIENT WAS IN PAIN, COULDN'T WALK, TROUBLE BREATHING AND COULDN'T LIFT ARM. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 TO REPLACE HARDWARE.
Patient problems: Ambulation or Postural Difficulties; Dyspnea; Fall; Injury; Pain
MAUDE report 8139682 ↗
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- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
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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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