MAUDE Adverse Event Report: MDT Puerto Rico Operations Co, Med Rel CD HORIZON® SOLERA® VOYAGER¿ Spinal System; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	55850047550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction

• Brand Name: CD HORIZON® SOLERA® VOYAGER¿ Spinal System
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 50400576
• Report Number: 2647346-2026-00466
• Device Sequence Number: 13049411
• Product Code: NKB
• UDI-Device Identifier: 00643169745360
• UDI-Public: (01)00643169745360(11)240515(10)H5956976
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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: 55850047550
• Device Catalogue Number: 55850047550
• Device Lot Number: H5956976
• 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: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Date Device Manufactured: 05/15/2024
• 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
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 225 LB