MAUDE Adverse Event Report: Medtronic Medical Costa Rica S.R.L. CD HORIZON® Spinal System; PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPA

Model Number	5531414
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Pressure Sore/Ulcer (2326)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a healthcare provider regarding a patient having revision surgery due to adult spinal deformity.In a repeat surgery case for adult spinal deformity following the initial surgery performed on (b)(6) 2024, hook dislodgement at the upper fixed end was reported for products 5531414 so56 transverse hook light and 5531415 so56 transverse hook left, both implanted at thoracic vertebra 4. patient underwent additional surgery to extend the fixation range upward and re-fix the construct following the reported dislodgement. the patient required hospitalization or extended care after discharging due to pressure ulcer and back pain, developed bedsore and back pain.  bone fusion was reported as not achieved immediately after surgery.There were no further complications reported.
Additional Manufacturer Narrative
H6 - neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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: PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPA
• 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 ; +1(763)526-5677
• MDR Report Key: 50686831
• Report Number: 3014725904-2026-00086
• Device Sequence Number: 13370976
• Product Code: OSH
• UDI-Device Identifier: 00643169347816
• UDI-Public: (01)00643169347816(17)320131(10)1007254W
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• 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: 5531414
• Device Catalogue Number: 5531414
• Device Lot Number: 1007254W
• 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: 01/31/2024
• 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