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

Model Number	G6626526
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
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.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 multiple sources (manufacturer representative, distributor) regarding a patient having spinal therapy for unknown indication.It was reported that the hcp placed the implant in position using the freehand inserter and put the screws.When they viewed via the microscope before engaging the locking mechanism, they saw a crack in the anterior portion of the implant near the locking mechanism.On seeing the crack on the implant, they removed the screws and replaced it with a new divergence stand-alone cage and finished the procedure.There was no patient symptom reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
B5.Desc evt problem updated 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 multiple sources (manufacturer representative, distributor) regarding a patient having spinal therapy for unknown indication.It was reported that the hcp placed the implant in position usingthe freehand inserter and put the screws.When they viewed via the microscope before engaging the locking mechanism, they saw a crack in the anterior portion of the implant near the locking mechanism.On seeing the crack on the implant, they removed the screws and replaced it with a new divergence stand-alone cage and finished the procedure.There was no patient symptom reported.There were no further complications reported regarding the event.(b)(6) 2024, update received the procedure was an acdf (anterior cervical discectomy and fusion) when the event occurred.
Additional Manufacturer Narrative
H3: product analysis #part : g6626746 : lot # 25re visual and optical inspection revealed the implant was returned damaged.The implant has cracked next to where the release/lock mechanism is.The implant is fragile and can be overloaded.The damage appears to be from overload during the implantation procedure 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: 20504132
• Report Number: 1030489-2024-01340
• Device Sequence Number: 8258229
• Product Code: OVE
• UDI-Device Identifier: 00643169337497
• UDI-Public: 00643169337497
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2025

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: G6626526
• Device Catalogue Number: G6626526
• Device Lot Number: 25RE
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 10/25/2024; 02/25/2025
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/07/2024; 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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 Age: 67 YR
• Patient Sex: Unknown