Skip to content

XIA II 03829630Recalls & reported problems

Stryker Corporation · POLYAXIAL REDUCTION SCREW · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154407866), received between Jun 20, 2017 and Jun 20, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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

  • Device Operates Differently Than Expected1
  • Improper or Incorrect Procedure or Method1
  • Mechanical Jam1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJun 20, 2017Mechanical Jam; Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected; Mechanical Jam

    IT WAS REPORTED THAT; DURING THE OPERATION, THE UNIVERSAL SCREW WAS IMPLANTED AND THE NAIL HEAD WAS UNABLE TO OPERATE AND THE SCREWS WERE NOT IMPLANTED PROPERLY. ADDITIONAL INFORMATION NOTED THE FOLLOWING; IT WOULD HAVE BEEN NECESSARY TO IMPLANT 6 SCREWS. BUT IN THE END, ONLY 5 SCREWS WERE FIXED TO PERFORM THE OPERATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6655094 ↗

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.