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

Model Number	LUN20006-12
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fluoroscopy images were received confirming the event.The middle segment of implant was not deployed correctly.As a result, the device was placed anteriorly of the vertebral body.Returned device was evaluated and evidence of excessive force was present.Implant met specifications except in damaged areas which could not be measured.The damage to the implants (rail and track) were likely the result of locking the posterior fixation hardware.The immobilization did not allow for implant expansion and distraction of the disc space during deployment of the device.Additionally the anterior annulus was noted to be compromised, possibly allowing for the malpositioning.
Event or Problem Description
Patient underwent tlif surgery on (b)(6) 2022, to fuse l5-s1.During deployment, the middle segment of the cage did not deploy correctly and was malpositioned anterior of the vertebral body.No patient injury occurred.Intra-operatively another static cage was used to complete the surgery.

• 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: 14780995
• Report Number: 3004893332-2022-00009
• Device Sequence Number: 14936398
• Product Code: MAX
• UDI-Device Identifier: 00840606164221
• UDI-Public: (01)00840606164221(10)211023(17)230701
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: LUN20006-12
• Device Catalogue Number: LUN20006-12
• Device Lot Number: 211023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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
• Patient Age: 71 YR
• Patient Sex: Female