LUNA XD LUN20006-10Recalls & reported problems
Spinal Elements, Inc. · 10MM, 6-DEGREE, LUNA XD IMPLANT KIT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840606164214), received between Mar 29, 2022 and Jan 9, 2025 — classified as 2 injuries.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Mechanical Problem1
- Migration1
Patient problems
- Failure of Implant1
- Limb Pain1
- Nerve Damage1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 9, 2025Fracture; Mechanical Problem; Fracture; Mechanical Problem
ON (B)(6) 2024, PATIENT UNDERWENT A TLIF PROCEDURE AT L4-L5. INTRA-OPERATIVELY THE MIDDLE SEGMENT OF THE IMPLANT FRACTURED DURING DEPLOYMENT AND COULD NOT BE EASILY RETRACTED. THE NERVE ROOT WAS INJURIED UPON RETRIEVING THE DAMAGED IMPLANT. A STATIC CAGE WAS IMPLANTED TO COMPLETE THE CASE. AS A RESULT THE PATIENT REPORTEDLY HAD RADICULAR PAIN ON LEFT SIDE. PATIENT WILL CONTINUED TO BE MONITORED.
Patient problems: Limb Pain; Nerve Damage
MAUDE report 21119632 ↗InjuryMar 29, 2022Migration; Migration
PATIENT UNDERWENT A PLIF PROCEDURE AT L5-S1, IN (B)(6) 2021. IN (B)(6) 2022, RADIOGRAPH RECEIVED NOTED THE IMPLANT HAD MIGRATED ANTERIORLY. REVISION SURGERY OCCURRED TO REPLACE THE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 13940415 ↗
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- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
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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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