OMEGA XP 72-02Recalls & reported problems
Spinal Elements, Inc. · OMEGA XP® INSERTER ASSY · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00840916142193), received between Apr 24, 2020 and Apr 24, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Most reported problems
Device problems
- Fracture1
- Mechanical Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2020Fracture; Mechanical Problem; Fracture; Mechanical Problem
ON (B)(6) 2020, PATIENT UNDERWENT A OLLIF PROCEDURE AT L4-S1. REPORTEDLY DURING THE PROCEDURE THE INSERTER DISLODGED FROM THE IMPLANT CAGE AT L5-S1. THEN THE SURGEON HAD TO IMPACT THE INSERTER TO ADVANCE THE IMPLANT, CAUSING THE PRONG TO FRACTURE OFF THE INSERTER. THE FRAGMENT COULD NOT BE SEEN ON FLUORO OR RADIOGRAPH, BUT ALSO COULD NOT BE CONFIRM TO BE SUCTIONED FROM THE SURGICAL SITE. THERE WAS NO INJURY TO PATIENT. IT IS UNKNOWN IF THE FRAGMENT REMAINS IN THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9998101 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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