MAUDE Adverse Event Report: WARSAW ORTHOPEDICS ZEVO ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD

Model Number	G3002037
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographic image review: lateral x-ray, 2 panels, 2 level cervical fusion, on right panel, there has been some subsidence, no hardware complication identified.This regulatory report is being submitted due to retrospective review through capa 624392.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having anterior cervical fusion for cervical spondylotic myelopathy.It was reported that on july 7, the zv wasinitially used.Less than 3 weeks after the surgery, dislodgement (migration) of the bone graft was observed.Comparative images of postoperative and most recent x-ray imaging were obtained.The grafted bone collapsed 20¿30° posteriorly.As a result, the l4 lowerendplate - the l6 upper endplate will decrease by 4-5 mm, and the c6 screw angle will be -10° (it was believed that the variable mechanism was activated).The patient received an iliac bone graft for the c5 corpectomy and plate fixation for the c4-6.The general flow of the procedure is as follows: deployment with a pin distractor, iliac bone grafting, and fixation with a plate.Since it wasfix-group, the grafted bone was more firm than loose; it was slightly tapped and inserted during the iliac graft.When distraction was loosened and checked, there was no feeling of movement, and it was steady.The vertebral endplate was also not disrupted.No sinking was observed, and it seemed like it had dislodged behind the cranial region.Fortunately, it did not reach the dura mater, and there are no symptoms (precisely, it seems to have been a transient pain, but it is said to have disappeared).It feels like it has been shortened, so the height has decreased, and the yellow ligament that had been extended seems to be slightly bent (from the mri).There is no pressure due to this at present.The position of the graft bone has changed, and the height has also changed.In this state, the variable has been activated for the time being and has been subdued.There was no other patient symptom reported.There were no further complications reported regarding the event.

• Brand Name: ZEVO ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21065363
• Report Number: 1030489-2025-00048
• Device Sequence Number: 20953337
• Product Code: KWQ
• UDI-Device Identifier: 00643169327504
• UDI-Public: 00643169327504
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2025

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 Model Number: G3002037
• Device Catalogue Number: G3002037
• Device Lot Number: 0896487W
• 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: 07/26/2023
• Initial Report FDA Received Date: 01/03/2025
• Date Device Manufactured: 04/22/2022
• 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 Sex: Unknown