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XIA II 03829545Recalls & 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 07613154407835), received between Jan 10, 2018 and Jan 10, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1
  • 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.

  • MalfunctionJan 10, 2018Break; Mechanical Jam; Mechanical Jam

    IT WAS REPORTED THAT; THE PATIENT WAS PLACED IN THE PRONE POSITION, THE ROUTINE SURGICAL DISINFECTION WITH THE TOWEL WAS PERFORMED. THE SURGICAL FIELD EXPOSURE WAS FULLY CLEAR, AND REGULAR OPEN CONE. THE ROAD OPENER TOOK THE PIN, PIN WAS SET AND THE POSITION OF THE PERSPECTIVE WAS GOOD. SCREW WAS IMPLANTED. AFTER THE PERSPECTIVE, SECOND SCREW WAS IMPLANTED . THE APPROPRIATE LENGTH WAS SELECTED AND THE SCREW PLUG WAS INSERTED. THE SCREW WAS BROKEN AND THE NAIL BROKE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7180298 ↗

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.