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XIA II 48218045Recalls & reported problems

Stryker Corporation · RAD ROD · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540433879), received between Sep 1, 2016 and Sep 1, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Biocompatibility1

Patient problems

  • Pain1
  • Reaction1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 1, 2016Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

    IT WAS REPORTED THAT; PATIENT RECEIVED A POSTERIOR LUMBAR DECOMPRESSION INFUSION AT L4-L5 IN (B)(6) 2014. SHE RECENTLY STARTED TO EXPERIENCE A LOT OF ACHING AND PAIN AND HER SURGEON SUGGESTS THIS MAY BE AN ALLERGIC REACTION TO THE IMPLANT.

    Patient problems: Pain; Reaction

    MAUDE report 5920657 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.