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ES2 SPINAL SYSTEM 482804735Recalls & reported problems

Stryker Corporation · LONG BLADE CANNULATED 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 07613327002218), received between Aug 22, 2016 and Aug 22, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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

  • Material Separation1
  • Mechanical Problem1

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.

  • MalfunctionAug 22, 2016Mechanical Problem; Material Separation; Mechanical Problem

    IT WAS REPORTED THAT; DURING SURGERY THE SURGEON TIGHTENED THE BLOCKER USING THE TORQUE WRENCH. WHEN THE SURGEON PULLED OUT THE TORQUE WRENCH, THE SCREW HEAD SEPARATED. THEREFORE THE SURGEON CHANGED THE SCREW TO ANOTHER SAME SIZE SCREW.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5894735 ↗

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.