MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	7078396
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy for lumbar kyphoscoliosis correction.It was reported that during a spinal surgery, th9/l1 and l3/sai were secured separately, and each was connected with the connector using the outer rod.After final tightening on the left side, the right side connector screw became stripped during insertion.Subsequent attempts to remove the stripped screw resulted in the t25 obturator being damaged and becoming stuck inside the assembly.Both the affected implant and instrument were explanted and replaced.There was a delay in the procedure of less than 60 minutes.There were no patient symptoms reported.There were no further complications reported regarding the event.Additional information was received from the manufacturer representative that when tightening the set screw on the top-open side of the connector for the final time, it turned freely and could not be screwed in.As a result, an attempt was made to remove the connector, but when trying to remove the set screw on the side-open side, the tip of the obturator broke off and became stuck.
Additional Manufacturer Narrative
H3: product analysis of product:7078396, lot:h6049709 visual and macroscopic inspection confirmed the threads of the break off screw have been damaged.The thread crest and flank damage appear to have initiated at the start of the thread and is consistent around the damaged portion of the thread.This type of damage consistent with the misalignment of the mas and set screw threads during the attachment process.E1: initial reporter is unknown 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: CD HORIZON® SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 23931666
• Report Number: 2647346-2025-00280
• Device Sequence Number: 5739179
• Product Code: KWP
• UDI-Device Identifier: 00643169210189
• UDI-Public: (01)00643169210189(17)330501(10)H6049709
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 12/31/2025

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: 7078396
• Device Catalogue Number: 7078396
• Device Lot Number: H6049709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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