MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ZEVO CERVICAL PLATE SYSTEM; SCREWDRIVER

Model Number	3030007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 3030007, serial/lot #: (b)(6), udi#: (b)(4); product id: 3030007, serial/lot #: (b)(6) and udi#: (b)(4).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 multiple instruments.It was reported that instruments were broken.There was no patient involved.
Additional Manufacturer Narrative
H3: product analysis : part # 3030007 : lot # k24a1505 visual and optical examination revealed the portion of the driver¿s tip that interfaces with the screw has been worn/stripped consistent with interface during usage.The torx edges have been slightly rolled over and deformed.The driver may have not been seated all the way down in the head of the screw before use.This type of damage is consistent with torsional overload.Product analysis : part # 3030007 : lot # k24a1505 visual and optical examination revealed the portion of the driver¿s tip that interfaces with the screw has been worn/stripped consistent with interface during usage.The torx edges have been slightly rolled over and deformed.The driver may have not been seated all the way down in the head of the screw before use.This type of damage is consistent with torsional overload.Product analysis : part # 3030007 : lot # im18h021 visual and optical examination revealed the portion of the driver¿s tip that interfaces with the screw has been worn/stripped consistent with interface during usage.The torx edges have been slightly rolled over and deformed.The driver may have not been seated all the way down in the head of the screw before use.This type of damage is consistent with torsional overload.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: SCREWDRIVER
• 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: 21392520
• Report Number: 1030489-2025-00821
• Device Sequence Number: 8787105
• Product Code: HXX
• UDI-Device Identifier: 00643169342293
• UDI-Public: 00643169342293
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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: 3030007
• Device Catalogue Number: 3030007
• Device Lot Number: K24A1505
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11....".; SEE H11.
• Patient Sex: Unknown