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Zodiac 22085Recalls & reported problems

Alphatec Spine, Inc. · ZODIAC TI HEXALOBE SET SCREW, 8.5MM · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844856043695), received between May 18, 2016 and May 18, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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

  • Migration or Expulsion of Device1

Patient problems

  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 18, 2016Migration or Expulsion of Device

    REVISION SURGERY WAS CONDUCTED ON (B)(6) 2016 ON A (B)(6) YEAR OLD FEMALE PATIENT. THE ZODIAC SET SCREWS LOCATED ON BOTH SIDES OF THE ILIAC WERE FOUND TO HAVE BACKED OUT OF POSITION. THE ZODIAC SPINAL FIXATION WAS ORIGINALLY IMPLANTED ON (B)(6) 2015 FROM THE T10 THRU PELVIS.

    Patient problems: No Code Available

    MAUDE report 5663158 ↗

Other Orthosis, spondylolisthesis spinal fixation devices

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