MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO., HU CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	55840016545
Medical Device Problem Codes	Nonstandard Device (1420); Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1:initial reporter:first name 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.
Event or Problem Description
Information was received from a healthcare professional via a manufacturer representative regarding a device used in a transpedicular lumbar instrumentation procedure (three levels implanted).It was observed on the back table that one tulip did not have internal threads, preventing the screwdriver from engaging or holding within the tulip.Importantly, there was no patient involvement or impact, and no further complications were reported.The screwdriver functioned properly with all other threaded screws, confirming that the issue was isolated to the tulip, which was found to lack internal threads and thus was not due to a device malfunction.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO., HU; road 909, km. 0.4; humacao,pr
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO., HU; road 909, km. 0.4; humacao,pr
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 24480203
• Report Number: 2647346-2026-00094
• Device Sequence Number: 18697358
• Product Code: KWP
• UDI-Device Identifier: 00643169077423
• UDI-Public: (01)00643169077423(11)250825(10)H6081996
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2026

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: 55840016545
• Device Catalogue Number: 55840016545
• Device Lot Number: H6081996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2025
• 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