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

Model Number	55740106550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 health care provider via manufacturing representative regarding a patient undergone l2-s1 posterior spinal fusion with tlif spacers at l3/4, l4/5 and l5-s1.It was reported that at the 3 months post-op visit, the surgeon observed screw fracture at the s1 screws, bilaterally.For the revision surgery.The surgeon exposed the previous hardware, removed the set screws and previous rods and crosslink.He then removed the broken tulip heads, then left the remaining screw shank in s1.The surgeon then placed bilateral iliac screws and placed a new rod and set screws.No further complications were reported/anticipated.

• 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: 22713122
• Report Number: 2647346-2025-00046
• Device Sequence Number: 9628022
• Product Code: KWP
• UDI-Device Identifier: 00643169052963
• UDI-Public: (01)00643169052963(17)291212(10)H5998239
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2025

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: 55740106550
• Device Catalogue Number: 55740106550
• Device Lot Number: H5998239
• 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: 07/10/2025
• Initial Report FDA Received Date: 08/05/2025
• Date Device Manufactured: 12/12/2024
• 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 Age: 68 YR
• Patient Sex: Male