Skip to content

XIA 4 5 481321120Recalls & reported problems

Stryker Corporation · TITANIUM PREBENT AND PRECUT ROD WITHOUT HEX · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327003321), received between Apr 8, 2019 and Apr 8, 2019 — classified as 2 malfunctions.

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

Most reported problems

Device problems

  • Migration2
  • Device Dislodged or Dislocated1
  • Device Slipped1

Patient problems

  • No Consequences Or Impact To Patient2
  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 8, 2019Device Dislodged or Dislocated; Migration; Migration

    IT WAS REPORTED THAT POST-OP X-RAY SHOWS ROD HAD PULLED OUT OF TOP SCREW. NO ADVERSE CONSEQUENCES TO THE PATIENT WAS REPORTED. NO REVISION SURGERY HAS BEEN SCHEDULED.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 8493178 ↗
  • MalfunctionApr 8, 2019Device Slipped; Migration; Migration

    IT WAS REPORTED THAT POST-OP X-RAY SHOW A ROD HAD PULLED OUT OF TOP SCREW. NO ADVERSE CONSEQUENCES TO THE PATIENT WAS REPORTED. NO REVISION SURGERY HAS BEEN SCHEDULED.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 8493177 ↗

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.