MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO., HU DIVERGENCE¿ ANTERIOR CERVICAL FUSION SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED F

Model Number	G6626746
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare professional via manufacturer representative regarding a spacer being used in spinal therapy.It was stated that the device fractured during implantation.Patient involved did not experience any symptoms as a consequence of this event.No further complications were reported regarding this event.Additional information was received as during implantation, the fusion cage fractured.After this occurred, it was immediately removed and there was a less than 60 mins delay in the procedure.It was stated that the procedure being carried out was fracture surgery with prosthesis implantation.
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): MEDTRONIC PUERTO RICO OPERATIONS CO., HU; road 909, km. 0.4; humacao,pr
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO., HU; road 909, km. 0.4; humacao,pr
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 25371425
• Report Number: 2647346-2026-00295
• Device Sequence Number: 13092534
• Product Code: OVE
• UDI-Device Identifier: 00643169337473
• UDI-Public: (01)00643169337473(17)300509(10)H5759288
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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: G6626746
• Device Catalogue Number: G6626746
• Device Lot Number: H5759288
• 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: 05/06/2026
• Initial Report FDA Received Date: 06/03/2026
• Date Device Manufactured: 05/09/2022
• 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: Unknown