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-2213
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a surgeon had a case where the lumbar cage implant had shifted post-operatively.The rep stated that the patient originally had a l4-5 tlif utilizing a 13mm implant.Patient required a revision surgery because the implant migrated posteriorly through the disc prep pathway.In the revision surgery, the surgeon increased the height of the implant to a 15mm height, which is evident in the a/p xray where there is less gap above and below the implant as was previously present on the 13mm.The patient again had the 15mm implant move posteriorly and required a revision surgery.The surgeon removed the 15mm implant and replaced it with a another manufacturer's expandable tlif implant.This is one of two related mdrs for this patient (this is for the first revision procedure).
Additional Manufacturer Narrative
Based on the information available, 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.

• 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 ; 4077854216
• MDR Report Key: 19541352
• Report Number: 3012429289-2024-00002
• Device Sequence Number: 7501854
• Product Code: MAX
• UDI-Device Identifier: 00818345024311
• UDI-Public: (01)00818345024311(17)270501(10)JI6404
• 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
• Device Explanted 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-2213
• Device Lot Number: JI6404
• 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 SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male