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Zodiac 62003-05Recalls & reported problems

Alphatec Spine, Inc. · TI ALLOY PRECONTOURED ROD 5.5DIA X 50MM · 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 00844856001824), received between Mar 31, 2016 and Mar 31, 2016 — classified as 1 malfunction.

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

  • Break1
  • Fracture1

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.

  • MalfunctionMar 31, 2016Break; Fracture

    REVISION SURGERY TOOK PLACE ON (B)(6) 2016 TO EXTEND AN EXISTING ZODIAC CONSTRUCT AT THE L4/5 VERTEBRAL BODY TO L2 THRU THE L5. THE EXTENSION WAS BEING PERFORMED BECAUSE THE UPPER NON-SUPERIOR SEGMENT FACET JOINT VIOLATION HAD BEEN CONFIRMED. DURING THE CASE, THE EXISTING SINGLE LEVEL ROD WAS FOUND TO BE FRACTURED AND BROKE. THE ZODIAC DEGENERATIVE SPINE FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2015.

    Patient problems: No Code Available

    MAUDE report 5538372 ↗

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.