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XIA 3 4823717540Recalls & reported problems

Stryker Corporation · MEDIAL BIASED ANGLE POLYAXIAL 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 07613252045731), received between Jan 10, 2019 and Jan 10, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1
  • Device Dislodged or Dislocated1

Patient problems

  • No Code Available1
  • No Consequences Or Impact 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, 2019Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component

    IT WAS REPORTED THAT SCREW HEAD DISLODGED FROM THE SCREW SHANK DURING REVISION SURGERY. ALL BROKEN FRAGMENTS WERE RETRIEVED AND ALL SCREWS WERE REMOVED. PER THE COMMUNICATION WITH REP., THE PATIENT FUSED AND THE REVISION SURGERY WAS FOR REMOVING HARDWARE. NO ADVERSE CONSEQUENCES TO THE PATIENT WAS REPORTED.

    Patient problems: No Code Available; No Consequences Or Impact To Patient

    MAUDE report 8237812 ↗

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.