MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	54850047545
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis: product# 54850047545; lot# unknown after visual and optical examination, it appears that the extended tabs on the screws have been jammed into the tab extenders.This regulatory report is being submitted due to retrospective review through capa 624392.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 a healthcare professional via manufacturer representative regarding a screw used in robotic guided pedicle screw placement lumbar 5 therapy for stenosis.It was reported that the patient was fine but when the surgeon tried snapping off the voyager 4.75 perc set screw it wouldn¿t break off.The handle would ¿skip¿ and not break off.It is thought that the screw maybe defective and maybe the setscrew splayed the head of the screw.It appeared to be slightly splayed.About 3 different setscrews were tried and then a longer rod.It was also tried to raise l4 to make l4 and 5 nearly identical in height.They had tried backing that screw off a bit even though screw was not buried in bone, it had full range of motion.Finally they replaced the screw with anther 7.5x45 and it worked.No additional surgery was performed.No patient symptoms were reported.No further complications were reported/anticipated.Additional information was received.It was reported that there were no other product malfunctions in this event.

• Brand Name: CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21581043
• Report Number: 1030489-2025-01296
• Device Sequence Number: 9467329
• Product Code: NKB
• UDI-Device Identifier: 00643169787506
• UDI-Public: 00643169787506
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2025

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: 54850047545
• Device Catalogue Number: 54850047545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 56 YR
• Patient Sex: Unknown