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

Model Number	G6626525
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis of part#: g6626525; lot#: h5856409 visual and optical inspection confirmed the cage has been cracked.The spacer is fragile and can be overloaded.The damage appears to be from excessive force placed on the implant during the inserting process.This regulatory report is being submitted due to retrospective review through capa: 624392.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 cervical hernia.It was reported that, the cage was broken when it was driven additionally using the trial as an impactor.The procedure or technique performed was anterior cervical discectomy and fusion and the levels planned were c6/c7.There was a delay of less than 60 minutes reported.There were no patient symptoms reported.No fragment of broken cage left inside the patient body.No additional treatment or surgery performed as a result.No further complications reported.

• 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: 21500897
• Report Number: 1030489-2025-01056
• Device Sequence Number: 19945573
• Product Code: OVE
• UDI-Device Identifier: 00643169337558
• UDI-Public: 00643169337558
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 03/02/2025

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: G6626525
• Device Catalogue Number: G6626525
• Device Lot Number: H5856409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 03/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2023
• 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