MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL CD HORIZON; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	75447540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
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 multiple sources (healthcare provider, distributor) regarding a patient having spinal fusion therapy for spondylolisthesis and lumbar stenosis at 2 levels l3l4 and l4l5.It was reported that the implant broke after implantation, and another surgery was required to remove the damaged screw.The patient reported hearing something breaking in their back just before discharge.An x-ray revealed that a screw had popped out, with the shaft and head separated, and a fragment of the implant remained in the patient until removal.The patient was alive with injury.Additional information was received from the manufacturer representative that the revision surgery had happened on (b)(6) 2025, prolongation of hospitalization happened due to the revision surgery to extract the damaged screw.All damaged fragments inside the patient has been removed.The actual date of initial surgery was on (b)(6) 2025 and date of removal was on (b)(6) 2025.
Additional Manufacturer Narrative
H3: product analysis of product: 75447540, lot: h6018273.Visual examination confirmed the legacy screw was returned with the bone screw shank separated from the pedicle head.Microscopic examination revealed the multi axial ring has been damaged also due to the bone screw shank pulling loose.The separation appears to be from overload as the root cause due to the shift anteriorly which put more strain on the lower lumbar screws.The internal testing shows a load of 3100n -5400n (tr12-249) depending on lmc/mmc to separate the head assembly from the shank.Radiographic image review indicated, antero posterior x-ray, l3-s1 fusion tulip and shaft separated on one side at s1.Lateral x-ray l3-s1 construct.Magnified view, a green circle shows the screw fracture at s1.Explanted hardware photo shows screw and tulip separated.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
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 23789928
• Report Number: 2647346-2025-00249
• Device Sequence Number: 5520513
• Product Code: KWP
• UDI-Device Identifier: 00885074134208
• UDI-Public: (01)00885074134208(11)241218(10)H6018273
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: 75447540
• Device Catalogue Number: 75447540
• Device Lot Number: H6018273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• 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; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Unknown
• Patient Weight: 62 KG