MAUDE Adverse Event Report: MSD DEGGENDORF MFG DIVERGENCE¿ ANTERIOR CERVICAL FUSION SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED F

Model Number	G6626746
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy.It was reported that, the distributor received a complaint regarding a spinal surgery performed on patient.The external technician informed that, while placing the independent cage 17mm x 14mm x 6mm, experienced a fracture of the device during the screw insertion process.The technician observed that the physician overtightened the screw and also mentioned that the screwdriver used did not have a torque limiter.The product was returned to the company after the surgery and will be stored in the rejected products warehouse until the importer retrieves it for further analysis.There was no patient symptom reported.There were no further complications reported regarding the event.
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.

• Brand Name: DIVERGENCE¿ ANTERIOR CERVICAL FUSION SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED F
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf,de 94469 ; GM 94469
• Manufacturer (Section G): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf,de 94469 ; GM 94469
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 22892494
• Report Number: 3011795235-2025-00010
• Device Sequence Number: 8851879
• Product Code: OVE
• UDI-Device Identifier: 00643169337473
• UDI-Public: (01)00643169337473(17)320311(10)H5905647
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K141599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2025

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: G6626746
• Device Catalogue Number: G6626746
• Device Lot Number: H5905647
• 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: 07/31/2025
• Initial Report FDA Received Date: 08/26/2025
• Date Device Manufactured: 03/11/2024
• 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: Female