MAUDE Adverse Event Report: SPINAL ELEMENTS, INC LUNA; INTERVERTEBRAL FUSION DEVICE- INSERTER ASSY

Catalog Number	LUN2006-10
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Codes	Nerve Damage (1979); Limb Pain (4836)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Radiographs confirming the event were received.Image of damaged device depicts the distal portion is broken off/missing (device was not returned/discarded).Unknown factors include: patient anatomy ( anatomical obstructions or collapsed disc space) and/or subsequent surgical technique/clinic elements (excess manipulation).Root cause cannot be determined.Review of labeling notes: possible adverse effects: "2.Disassembly, bending, and/or breakage of any or all components.7.Dural tears, persistent csf leakage, meningitis.8.Loss of neurological function including paralysis (partial or complete), radiculopathy, and/or the development or continuation of pain, numbness, spasms, or sensory loss.".
Event or Problem Description
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.

• Brand Name: LUNA
• Common Device Name: INTERVERTEBRAL FUSION DEVICE- INSERTER ASSY
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer Contact: peter perhach ; 3115 melrose drive; suite 200; carlsbad, CA 92010 ; 7606071830
• MDR Report Key: 21119632
• Report Number: 3004893332-2025-00001
• Device Sequence Number: 15624003
• Product Code: MAX
• UDI-Device Identifier: 00840606164214
• UDI-Public: (01)00840606164214(10)154230(17)251231
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K183560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: LUN2006-10
• Device Lot Number: 154230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female