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

Model Number	55750015540
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Unspecified Nervous System Problem (4426)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having l3/s2 spinal therapy for an indication of lumbar canal stenosis (lcs).It was reported that there was s2screw misalignment.The screw was inserted according to the plan using the mazor system and postoperative ct confirmed that the s2 screw was inserted along the sacroiliac joint, with the screw threads protruding into the pelvis.The patient presented neurological symptoms and the attending physician's opinion is that the patient's postoperative neurological symptoms are likely due to the deviation of the l5 screw which was inserted freehand because the mazor system could not be used.There was a delay of less than 60 mins reported in overall procedure time.There was extension of existing hospitalization as a result of the event and the patient was scheduled for repeat surgery on (b)(6) 2025 for screw replacement.There were no further complications reported regarding the event.Additional information was received regarding the event.The patient was having pps spinal therapy.The revision surgery was performed successfully on (b)(6) 2025 and the direction of s2 and l5 screws was changed and replaced with new ones in additional surgery.
Additional Manufacturer Narrative
A: select patient information cannot be included in regulatory report due to regional privacy regulations.D4: it was not possible to determine which of the reported screws (product id 55750015540) - lot no.H5950618, lot no.H5964877, lot no.H5989911, or lot no.H6008226 was failed in the event.Therefore, all potentially affected screws are being reported.G2: the country of the event is japan.Radiographic image review: the axial ct shows sacral screw threads present into the si joint space bilaterally.Axial ct of different slice shows left si joint with distal screw threads on it.Also, some isolation of right si joint in cortical imaging.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
Additional information was received regarding the event.Surgery was performed for lcs without l5 radicular symptoms.Screw was inserted using mazor and the screw deviated into the spinal canal and radicular symptoms occurred.Re-operation occurred and it was re-inserted by freehand.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
Additional information: b5.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: 21880673
• Report Number: 1030489-2025-01809
• Device Sequence Number: 8632136
• Product Code: NKB
• UDI-Device Identifier: 00643169783768
• UDI-Public: 00643169783768
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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: 55750015540
• Device Catalogue Number: 55750015540
• Device Lot Number: H5964877
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/15/2025
• Date Device Manufactured: 06/26/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown