LUCENT P11351-508Recalls & reported problems
Spinal Elements, Inc. · LUCENT XP® 10X27X8MM 5°-10° · Class 2 · Implant
Data updated Oct 13, 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 00840606114882), received between Jun 3, 2021 and Jun 3, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (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
- Mechanical Problem1
- Migration1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2021Mechanical Problem; Migration; Mechanical Problem; Migration
ON (B)(6) 2020 PATIENT RECEIVED AN INTERBODY DEVICE AT L5-S1. PATIENT WAS ASYMPTOMATIC FOR APPROXIMATELY 7 MONTHS POST-OPERATIVELY, WHEN DISPLAYED LOCALIZED PAIN IN HIP AND BUTTOCK AREA. REPORTEDLY UPON EVALUATION, THE DEVICE HAD MIGRATED POSTERIORLY. RADIOGRAPHS WERE NOT RECEIVED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2021.
Patient problems: Pain
MAUDE report 11935980 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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