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

Model Number LUN20006-12

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 303095700
• Report Number: 3004893332-2022-00009
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00840606164221
• UDI-Public: (01)00840606164221(10)211023(17)230701
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female