MAUDE Adverse Event Report: MSD Deggendorf Mfg CLYDESDALE PTC¿ Spinal System; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	4986855
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having oblique lumbar interbody fusion procedure at l2-5 for spinal canal stenosis.It was reported that the cage was damaged during insertion at l4/5, and it was determined that complete fragment removal would be difficult; hence, fragments reportedly remained in the patient.The treatment was changed to iliac bone grafting and rear fixation, and the procedure was delayed by more than 60 minutes.No further complications were reported in relation to the event.Additional information was received that a broken fragment of part of the damaged cage remained in the body.At the time of insertion, the intervertebral space was narrow and, at l4/5, the ilium was obstructing.
Additional Manufacturer Narrative
E1: initial reporter is unknown.B2: outcome attributed to adverse event is additional surgery.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: CLYDESDALE PTC¿ Spinal System
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MSD Deggendorf Mfg; wertstrasse 17; deggendorf,de 94469 ; GM 94469
• Manufacturer (Section G): MSD Deggendorf Mfg; wertstrasse 17; deggendorf,de 94469 ; GM 94469
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; +1(763)526-5677
• MDR Report Key: 50688131
• Report Number: 3011795235-2026-00059
• Device Sequence Number: 5279554
• Product Code: MAX
• UDI-Device Identifier: 00643169190511
• UDI-Public: (01)00643169190511(17)321113(10)03RW
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133205
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4986855
• Device Catalogue Number: 4986855
• Device Lot Number: 03RW
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 11/13/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown