MAUDE Adverse Event Report: HT MEDICAL, LLC DBA XENIX MEDICAL NEOWAVE LS LUMBAR STRAIGHT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	23-LCT-2211
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information available, the loosening of the pedicle screw system that was used allowed the construct to loosen allowing the lumbar implant to migrate.Other contributing factors include not following the xenix system labeling.The surgeon originally used another manufacturer's interbody paddle sizers and shavers that were parallel in design and not provided by xenix.This causes the height of the disc space to be falsely measured at the lowest point in the disc space, instead of using xenix provided sizer and shavers that are anatomic and matching the convexity of the implants, which would allow for proper sizing of the space relative to xenix implant designs.The parallel shavers also cause a trough to be cut in the posterior lip of the vertebral body which, if left intact, assist with a physical barrier of bone to prevent implant migration.The system labeling was not followed: either xenix implant trials or the xenix paddle distractors are to be used to determine implant sizing.
Event or Problem Description
It was reported that a surgeon had a case in which the lumbar cage implant had shifted post-operatively.The rep said that the interbody at l2-3 migrated posteriorly.Imaging revealed the posterior migrated implant as well as signs of potential screw loosening at the l2 screw.During the revision surgery, it was discovered that the l2 pedicle screw caps in the pedicle screw tulip used for fixation had loosened allowing the rod to shift.Note - the pedicle screw system is from another manufacturer (unknown) and is not a xenix medical product.During the revision procedure, the lumbar cage implant was shifted back into position and the set screw was replaced and the construct was tightened.

• Brand Name: NEOWAVE LS LUMBAR STRAIGHT
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): HT MEDICAL, LLC DBA XENIX MEDICAL; 111 w jefferson st; suite 100; orlando FL 32801
• Manufacturer Contact: teresa cherry ; 111 w jefferson st; suite 100; orlando, FL 32801 ; 4074854216
• MDR Report Key: 19543337
• Report Number: 3012429289-2024-00001
• Device Sequence Number: 7606387
• Product Code: MAX
• UDI-Device Identifier: 00818345024298
• UDI-Public: (01)00818345024298(17)270501(10)JI6540
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 23-LCT-2211
• Device Lot Number: JI6540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PEDICLE SCREW FIXATION SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 86 KG