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

Model Number	55750026550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B2: outcome attributed to adverse event is additional surgery due to instrument malfunction.G2: the country of the event is germany.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 the healthcare professional via a manufacturer representative regarding a device used for spinal therapy.It was reported that the patient was treated with a spondylodese transforaminal lumbar interbody fusion at 16.4.26 at segment l5/s1, with voyager and capstone cage.The patient returned for a follow-up examination in july and reported pain; an x-ray taken at the clinic revealed that the 6.5 x 50 mm screw at s1 (left side) was broken.The screw was removed and replaced with a new one on (b)(6), 2026.There were no patient symptoms reported.There were no further complications reported regarding the event.

• 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: 50782904
• Report Number: 2647346-2026-00502
• Device Sequence Number: 13389488
• Product Code: PML
• UDI-Device Identifier: 00763000148843
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K201362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: 55750026550
• Device Catalogue Number: 55750026550
• Device Lot Number: H6061646
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 06/11/2025
• 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 Age: 38 YR
• Patient Sex: Female
• Patient Weight: 176 LB