MAUDE Adverse Event Report: MEDTRONIC MEDICAL COSTA RICA S.R.L. CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	5540030
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from health care provider via manufacturing representative regarding a product used in spinal therapy.It was reported that the set screw could not be turned into the screw.No patient was involved in this event.No further complications were reported/anticipated.The doctor wanted to implant the set screw in the patient and it did not go into the screw head.The doctor then used a new set screw.
Additional Manufacturer Narrative
H3: product analysis # (b)(4), product: 5540030, lot# 0059717c 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.Functional evaluation with a sample mas found the set screw unable to be fully engaged in the mas head.This is consistent with misalignment of the mas and set screw threads during construct assembly.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.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): MEDTRONIC MEDICAL COSTA RICA S.R.L.; coyol free zone building b7; multi-tenant 7-8; coyol 20113 ; CS 20113
• Manufacturer (Section G): MEDTRONIC MEDICAL COSTA RICA S.R.L.; coyol free zone building b7; multi-tenant 7-8; coyol 20113 ; CS 20113
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21870523
• Report Number: 3014725904-2025-00105
• Device Sequence Number: 15395092
• Product Code: KWP
• UDI-Device Identifier: 00613994966476
• UDI-Public: 00613994966476
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 04/21/2025

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: 5540030
• Device Catalogue Number: 5540030
• Device Lot Number: 0059717C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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
• Patient Sex: Unknown