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

Model Number	6541104
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient undergoing posterior fixation for rod fracture and re-anchoring.Levels implanted at (b)(6).It was reported that after final fastening, when attempting to remove the product, it could not be detached from the screw head despite the lock being released.It is believed that the adjacent extender body interfered, leaving no space to move the extender even with the lock released, causing it to get stuck and not detach.A part of the tip was damaged.There was no patient symptom reported.There were no further complications reported regarding the event.Additional information received from manufacturer representative that post-operative infection was confirmed after the initial surgery and cleaning was performed.The date of onset is unknown; no implant malfunctions were confirmed at this time.Afterwards, left rod fracture, loose set screws in the right sacral iliac, and backout of the l5/s cage were confirmed, and repeat surgery was performed on (b)(6) 2024.No patient symptoms are associated with the malfunction.Screw was added for postoperative infections.No defects in the implant itself additional information received from manufacturer representative that there is no causal relationship between post-operative infection and rod, set screw and cage due to implant.Cage backout, rod fracture and set screws did not cause any neurological symptoms.Additional information received from manufacturer representative that there is no malfunction with the extender.
Additional Manufacturer Narrative
H6: neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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® 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: 20770102
• Report Number: 1030489-2024-01559
• Device Sequence Number: 4399854
• Product Code: NKB
• UDI-Device Identifier: 20763000211213
• UDI-Public: 20763000211213
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2024

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: 6541104
• Device Catalogue Number: 6541104
• Device Lot Number: H5890463
• 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: 10/30/2024
• Initial Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2023
• 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
• Patient Sex: Unknown