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LUCENT P11351-011Recalls & reported problems

Spinal Elements, Inc. · LUCENT XP® 10X27X11MM 10°-15° · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840606114868), received between Jul 27, 2023 and Jul 27, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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

  • Adverse Event Without Identified Device or Use Problem1
  • Migration1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

    ON (B)(6)2023, DURING ROUTING FOLLOW UP IT WAS REPORT THAT AN INTERBOADY CAGE AT L4-L5 HAD ALLEGEDLY MIGRATED POSTERIORLY. PATIENT WAS ASYMPTOMATIC. INITIAL SURGERY DATE WAS NOT REPORTED. REVISION OCCURRED (B)(6)2023 TO REMOVE THE INTERBODY, BUT NO ADDITIONAL IMPLANTS WERE REPORTEDLY PLACED. RADIOGRAPHS WERE NOT RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17410442 ↗

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