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Invictus 15620Recalls & reported problems

Alphatec Spine, Inc. · Modular Extended Tab Polyaxial Reduction Tulip · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190376236124), received between Nov 4, 2020 and Aug 4, 2022 — classified as 1 injury, 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
  • Unintended Movement1

Patient problems

  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 4, 2022Unintended Movement; Unintended Movement

    AT THE 6-WEEK POSTOPERATIVE VISIT, RADIOGRAPHS REVEALED THE LEFT L5 ROD WAS DISENGAGED FROM THE TULIP. THE PATIENT IS ASYMPTOMATIC AND NO ADDITIONAL TREATMENT IS PLANNED AT THIS TIME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15170072 ↗
  • MalfunctionNov 4, 2020Material Separation

    FOLLOW UP X-RAY REVEALED THE TULIP OF THE MOD SCREW HAD SEPARATED FROM THE SHANK. THE TULIP REMAINS ATTACHED TO THE ROD IMPLANTED WITHIN THE PATIENT.

    Patient problems: Insufficient Information

    MAUDE report 10785649 ↗

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.