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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from health care provider via manufacturing representative regarding a patient undergoing spine surgery for l3/4 stenosis with right l3 radiculopathy.It was reported that the set screws that were placed at l3 had observable metal stripped off the thread when being inserted.One piece was aspirated into the surgical suction and one piece remained attached to the set screw.No patient symptoms reported and no revision surgery performed due to this event.No fragment of the implant remaining in the patient.No further complications were reported/anticipated.Additional information was received from the rep that procedure performed was an open posterior l3/4 decompression and fixation.
Additional Manufacturer Narrative
H3: product analysis #(b)(6): product :5540030 lot# 0042059c set screw location within construct unknown.Microscopically examined set screw rod interface node and surface.Threads do not show evidence of cross threading, however there is a burr/area where the initial thread has rolled over on the face of the set screw, and this could have been from misalignment when starting the screw.No exact root cause could be determined at this time.*originally the return had qty.Of 2for pli 10, as part of capa 624392 remediation each part has been given its own pli* 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.

• 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: 21879701
• Report Number: 3014725904-2025-00106
• Device Sequence Number: 8742103
• Product Code: KWP
• UDI-Device Identifier: 00613994966476
• UDI-Public: 00613994966476
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/22/2025

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: 0042059C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• 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