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

Model Number	2922055
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
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.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 a healthcare provider (hcp) via a manufacturer representative regarding a patient having multi-stage arthrodesis surgery, lumbar arthrodesis using an anterior approach, lumbar arthrodesis (a-lif) l5-s1 and multi-stage anterolateral lumbar arthrodesis(o-lif) l3-l4 and l4-l5.It was reported that during l4-l5 o-lif, an attempt was made to implant a cage.During implantation, the cage failed at the junction between the implant holder and the cage.During olif l3-l4 for another cage, the same incident occurred.Device was implanted and explanted on same day.Operative time extended by 15 minutes.Product came in contact with the patient.There were no patient symptoms reported and there was no revision surgery planned/ occurred as a result of the event.There were no further complications reported regarding the event.

• 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: 21400230
• Report Number: 1030489-2025-00830
• Device Sequence Number: 20886694
• Product Code: MAX
• UDI-Device Identifier: 00613994972897
• UDI-Public: 00613994972897
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113528
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2025

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 Expiration Date: 04/07/2024
• Device Model Number: 2922055
• Device Catalogue Number: 2922055
• Device Lot Number: 95BV
• 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: 11/20/2023
• Initial Report FDA Received Date: 02/18/2025
• Date Device Manufactured: 04/07/2016
• 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