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

Model Number	54850016550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider, distributor) regarding a patient having l4-5 transforaminal lumbar interbody fusion (tlif) surgery.It was reported that during an l4-5 tlif surgery, the extension blade of the device was broken.The surgery was successfully completed.No patient complications have been reported as a result of this event.Additional information was received via manufacturer representative that there were no broken fragments left inside patient as all were removed.
Additional Manufacturer Narrative
G2: country of origin is taiwan.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.
Additional Manufacturer Narrative
H3: product analysis of product# 54850016550, lot# h5948278 the tabs are made to break off the screw no fault found.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® 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: 21685712
• Report Number: 1030489-2025-01524
• Device Sequence Number: 15773405
• Product Code: NKB
• UDI-Device Identifier: 00643169491571
• UDI-Public: 00643169491571
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K143375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: 54850016550
• Device Catalogue Number: 54850016550
• Device Lot Number: H5948278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2025
• Supplement Date Received by Manufacturer: 05/03/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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 Sex: Male