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OMEGA XP 72-00-092810-00Recalls & reported problems

Spinal Elements · OMEGA XP™ 9MM X 28MM X 10MM 0° LUMBAR EXPANDABLE INTERBODY · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840916124618), received between May 25, 2018 and Aug 28, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Mechanical Problem2
  • Migration2
  • Collapse1
  • Migration or Expulsion of Device1

Patient problems

  • Nervous System Injury1
  • Neurological Deficit/Dysfunction1
  • No Code Available1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 28, 2020Mechanical Problem; Migration; Mechanical Problem; Migration

    ON (B)(6) 2020, PATIENT UNDERWENT A OLLIF PROCEDURE AT L4-L5. REPORTEDLY DURING ROUTINE FOLLOW UP, THE RADIOGRAPH NOTED THE IMPLANT AT L4-L5 WAS NOW POSTERIOR FROM INTENDED PLACEMENT. PATIENT IS ASYMPTOMATIC. IMPLANT WAS REVISED ON (B)(6) 2020.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10469129 ↗
  • MalfunctionMay 29, 2020Collapse; Mechanical Problem; Migration; Collapse; Mechanical Problem; Migration

    ON (B)(6) 2020, PATIENT UNDERWENT A OLLIF PROCEDURE AT L4-S1. REPORTEDLY DURING ROUTINE FOLLOW UP, THE RADIOGRAPH NOTED THE IMPLANT AT L4-L5 WAS NOW POSTERIOR FROM INTENDED PLACEMENT. PATIENT IS ASYMPTOMATIC.

    Patient problems: No Code Available

    MAUDE report 10103396 ↗
  • InjuryMay 25, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

    AFTER RECEIVING OLIF SURGERY PATIENT REPORTEDLY HAD CONTINUED LEG PAIN. IT IS UNKNOWN IF THE SYMPTOMS WERE RECURRING OR NEW. IT IS UNKNOWN IT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. ORIGINAL SURGERY DATE WAS NOT GIVING AND DURATION OF IMPLANTATION IS UNKNOWN. REVISION SURGERY OCCUR ON (B)(6) 2018 AND THE IMPLANT WAS REMOVED AND DISCARDED. NO IMAGE OR FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Nervous System Injury; Neurological Deficit/Dysfunction

    MAUDE report 7546811 ↗

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Sources and updates

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