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	Positioning Failure (1158); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from a health care provider via manufacturing representative regarding a device used for spinal therapy.It was reported that the surgeon appropriately placed implant into disc space using freehand inserter.Unfortunately he decided to remove the inserter after placement, and proceeded to drill through cage holes, without any guide holding implant in place.He suggested the cage was shifting and decided to place one screw through the cage to stabilize and he proceeded to drill the second hole, again with no guide holding implant stable.Cage sunk down into the spinal canal.He was able to retrieve it and remove screw.He decided to use the divergence cage as only a spacer, and decided to plate the space with screws.Surgeon chose to use a stand alone device (divergence) due to the fact that the patient had adjacent level disease, and did not want to remove old hardware.There were no patient symptoms reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
Radiographic image review comments updated.1.Lateral x ray c4-5 acdf, c5 - level unknown acdf below that.2.Intra op lateral view, an interbody graft and inserter is seen along with a kesper pin in one of the vertebral level.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 94469 ; GM 94469
• Manufacturer (Section G): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469 ; GM 94469
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21372452
• Report Number: 1030489-2025-00769
• Device Sequence Number: 3849780
• Product Code: OVE
• UDI-Device Identifier: 00643169337473
• UDI-Public: 00643169337473
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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: H5543898
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2019
• 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 Age: 53 YR
• Patient Sex: Female