Luna 3D LUN3011Recalls & reported problems
Benvenue Medical, Inc. · 11mm Luna 3D Parallel Implant Kit · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00813478020285), received between Nov 21, 2018 and Nov 21, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Migration1
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.
InjuryNov 21, 2018Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration
ON OCTOBER 25, 2018, BENVENUE RECEIVED INFORMATION OF A DEVICE MIGRATION REQUIRING REVISION SURGERY TO RESOLVE. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2018. THE DATE OF THE ORIGINAL SURGERY WAS (B)(6) 2018. A LUNA 1.0 (LUN3011) WAS IMPLANTED AT L5/S1. THE INITIAL IMPLANTATION WAS COMPLETED WITHOUT INCIDENT. ACCORDING TO THE TREATING PHYSICIAN, THE PATIENT FELT PAIN WHILE PERFORMING AGGRESSIVE PHYSICAL THERAPY IN THE (B)(6) TIMEFRAME. IMAGING AT THAT TIME SHOWED THAT THE LUNA IMPLANT HAD DISASSEMBLED AND A PORTION HAD MIGRATED POSTERIORLY INTO THE SPINAL CANAL. THE SURGEON OPTED TO WAIT UNTIL FUSION WAS COMPLETE BEFORE ATTEMPTING TO SURGICALLY TREAT THE PATIENT. FUSION WAS CONFIRMED VIA CT SCANS IN LATE (B)(6) 2018. ON (B)(6) 2018, REVISION SURGERY WAS PERFORMED DURING WHICH THE SURGEON WAS ABLE TO SUCCESSFULLY CORRECT THE ISSUE BY REMOVING A PORTION OF THE DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8095829 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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