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

Model Number	3030007
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 spinal therapy for c4-c7 revision and fixation.It was reported that the tip was broken on two different drivers when the screw was used in the normal hole and not the slot hole.There were no further complications or symptoms reported regarding the event.Additional information was received via manufacturer representative that procedure involved in the event was anterior cervical discectomy and fusion (acdf) with cages and plate.There were broken fragments of driver kept in the screw head as it couldn¿t be removed.This was also due to user error as a 4.5mm slot screw should only be used in a slot hole and not in a normal hole made for 3.5/4.0mm va sd/st screws.The procedure was longer but there were no patient complications.
Additional Manufacturer Narrative
Radiographic assessment concluded that lateral x-ray shows three level anterior cervical discectomy and fusion (acdf) uncountable, no obvious hardware complication.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
Additional information was received via manufacturer representative that the other screws were implanted properly in to the plate without any fragments.There is no revision surgery planned for extraction of the screws or the plate.The screw driver tip was hard to retrieve so its in the screw head.
Additional Manufacturer Narrative
H3: product analysis of part # 3030007, lot# k24c1058.Visual and optical examination revealed the portion of the driver¿s tip that interfaces with the screw is broken.The damage to the driver is consistent with 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: 23231332
• Report Number: 3003120897-2025-00319
• Device Sequence Number: 9905896
• Product Code: HXX
• UDI-Device Identifier: 00643169342293
• UDI-Public: (01)00643169342293(11)240311(10)K24C1058
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2026

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: K24C1058
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 11/18/2025; 01/23/2026
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 12/10/2025; 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 59 KG