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Zodiac 62065-40Recalls & reported problems

Alphatec Spine, Inc. · TI STANDARD POLYAXIAL SCREW ASSY, 6.5MM x 40MM · 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 00844856003019), received between Jun 1, 2016 and Jun 1, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1

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.

  • InjuryJun 1, 2016Detachment of Device or Device Component

    REVISION SURGERY WAS CONDUCTED ON (B)(6) 2016 TO REMOVE AND REPLACE A ZODIAC SET SCREW AT THE T8. THE SET SCREW WHICH HAD BECOME DISENGAGED FROM THE POLYAXIAL SCREW, WAS REMOVED FROM THE PATIENT WITHOUT ISSUE.

    Patient problems: No Code Available

    MAUDE report 5692534 ↗

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