MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ZEVO CERVICAL PLATE SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	3032028
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having c4/5/6 ossifica tion of anterior longitudinal ligament and cervical anterior fusion.It was reported that when attempting to grasp the zevo plate using the dts guide, it could not be securely held, and the looseness was significant.The protrusion of the dts guide did not fit into the slot located on the side of the plate.The same issue occurred even when using thezv dts adjustable clamp. there was no patient involvement reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
G2: the country of the event is japan.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.
Additional Manufacturer Narrative
Additional information: d9, h3, h6 h3.Device evaluation summary: product analysis #(b)(4), part # 3032028 lot # nm16h086.Visual and functional inspection confirmed the guide is worn from repeated use.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.

• Brand Name: ZEVO CERVICAL PLATE SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 22491411
• Report Number: 1030489-2025-02423
• Device Sequence Number: 4106466
• Product Code: LXH
• UDI-Device Identifier: 00643169342385
• UDI-Public: (01)00643169342385(11)160916(10)NM16H086
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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: 3032028
• Device Catalogue Number: 3032028
• Device Lot Number: NM16H086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown