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Lumbar Plate System 1Recalls & reported problems

Genesys Orthopedics Systems LLC · Lumbar Plate Helios Driver - Assembly · Class 2

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 M719GLP1590), received between Feb 28, 2022 and Feb 28, 2022 — 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

  • Foreign Body In Patient1

Recent adverse event reports

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

  • MalfunctionFeb 28, 2022Break; Fracture; Break; Fracture

    DURING A BINARY LUMBAR PLATE PROCEDURE THE TIP OF THE THREADED INNER SHAFT OF THE LUMBAR PLATE DRIVER BROKE OFF (SEPARATED) IN THE HEAD OF A LUMBAR PLATE SCREW. THE REPRESENTATIVE COVERING THE CASE STATED THERE WERE NO ABNORMALITIES DURING INSERTION OF THE SCREW AND NOTHING EXTRAORDINARY OCCURRED PRIOR TO THE INSTRUMENT FAILURE. THE BROKEN PORTION OF THE INSTRUMENT COULD NOT BE RETRIEVED FROM THE SCREW AND WAS SUBSEQUENTLY IMPLANTED IN THE PATIENT.

    Patient problems: Foreign Body In Patient

    MAUDE report 13620342 ↗

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