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

Model Number	LUN20006-10
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Radiographs confirming the event were received.Device appears to be intact and properly aligned, spite the migration anteriorly.Revision occurred, but the device was not released by the hospital, not returned and could not be evaluated.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the condition of the anterior ligament, the degree of spinal instability, the longevity/the degree of pseudarthrosis or patient compliance with post-operative care instructions or if the patient sustained a fall/impact of any sort (no trauma was reported.).Root cause of the implant being anterior from intended placement cannot be determined.
Event or Problem Description
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.

• 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: 13940415
• Report Number: 3004893332-2022-00007
• Device Sequence Number: 6701732
• Product Code: MAX
• UDI-Device Identifier: 00840606164214
• UDI-Public: (01)00840606164214(10)210741(17)230701)
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K183560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2022

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: 07/01/2023
• Device Model Number: LUN20006-10
• Device Catalogue Number: LUN20006-10
• Device Lot Number: 210741
• 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: 03/05/2022
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male