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ES2 SPINAL SYSTEM 482804540Recalls & 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 07613327002133), received between Dec 13, 2016 and Dec 13, 2016 — classified as 1 malfunction.

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

  • Fracture1
  • Split1

Patient problems

  • Foreign Body In Patient1
  • 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.

  • MalfunctionDec 13, 2016Fracture; Fracture; Split

    IT WAS REPORTED THAT AT THE PATIENTS SIX WEEK FOLLOW UP APPOINTMENT IT WAS NOTICED THAT A PORTION OF A TAB WAS RETAINED IN THE PATIENT. THEY TAB SNAPPED ABOVE THE REDUCTION THREAD.

    Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

    MAUDE report 6170093 ↗

Other Orthosis, spondylolisthesis spinal fixation devices

All Orthosis, spondylolisthesis spinal fixation devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.