MAUDE Adverse Event Report: MSD DEGGENDORF MFG CLYDESDALE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	2922450
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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 received from clinical study, healthcare provider via manufacturer representative regarding a patient.An assessment for product/therapy/procedure relatedness was made by the investigator.This ae related to a study procedure was possible.There was procedure relationship.The ae was not related to the infuse.The ae was not related to devices/components other than infuse.The ae was not related to an underlying condition or disease.The amount of bleeding during the procedure was a little high, but was not related to infuse.An assessment for product/therapy/procedure relatedness was made by the sponsor - different from investigator.This ae related to a study procedure: causal relationship ae term: blood loss occurred during surgery blood loss occurred during surgery, so blood transfusion was performed.There are no additional records in the emr.The ae result in treatment.Blood transfusion was done as a result of ae.The patient outcome was recovered.The ae end: on (b)(6) 2024, seriousness criterion: medical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function: yes, the date the site became aware of the sae: on (b)(6) 2024, additional information was received that implant levels involved in the procedure were l3-l4.Patient experienced t wave inversion on (b)(6) 2024.Cage migration on (b)(6) 2024.Cage reposition was performed, no hospitalization.

• Brand Name: CLYDESDALE SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• 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: 21271724
• Report Number: 1030489-2025-00452
• Device Sequence Number: 3916148
• Product Code: MAX
• UDI-Device Identifier: 00613994972446
• UDI-Public: 00613994972446
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K113528
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/30/2025

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: 2922450
• Device Catalogue Number: 2922450
• Device Lot Number: 13NC
• 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: 01/08/2025
• Initial Report FDA Received Date: 01/30/2025
• Date Device Manufactured: 08/24/2022
• 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 Age: 81 YR
• Patient Sex: Unknown