MAUDE Adverse Event Report: MDT Puerto Rico Operations Co, Med Rel CD HORIZON® Fenestrated Screw Spinal System; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	55750026545
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from the health care professional via a manufacturer representative regarding a device used for l2-5 lateral lumbar interbody fusion, l2-l5 ercutaneous pedicle screw fixation, l2, l4, l5 femoral neck system procedures.The preoperative diagnosis for this surgery was l2/3/4/5 lumbar spinal canal stenosis with degenerative scoliosis.It was reported that during intra-op,when filling the cement, it felt harder than usual.During cement insertion on the right side of l2, there was a hard feeling, but imaging was also confirmed and filling was continued as is.Cement leakage was confirmed when the device was removed.Therefore, the right l2 screw was replaced with a standard mas.After removal, it was confirmed that the cement had not reached the hole at the tip of the screw and that almost all of it had leaked into the head.The device had been inserted slightly obliquely, and the confirmation button was also in a state where it could be pressed slightly.There were no patient symptoms reported.There were no further complications reported regarding the event.
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.

• Brand Name: CD HORIZON® Fenestrated Screw Spinal System
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• 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 ; +1(763)526-5677
• MDR Report Key: 50912801
• Report Number: 2647346-2026-00547
• Device Sequence Number: 5776403
• Product Code: PML
• UDI-Device Identifier: 00763000148836
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201362
• Number of Events Summarized: 1
• Summary Report (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): 09/28/2026

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: 55750026545
• Device Catalogue Number: 55750026545
• Device Lot Number: H6046203
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 04/15/2025
• 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