MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® FENESTRATED SCREW SET; DISPENSER, CEMENT

Model Number	6550041
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a fns tip and cement delivery gu ide used on patient having laminectomy therapy, stabilization with voyager 5.5 implants for d12 fracture on osteoporotic patient.It was reported that the cement leaked between tips and screws.The surgeon was forced to removed a screw because a tip was impossible to remove from the tulip.Guide didn't securely hold the tip and often the tip remained engaged in the screw tulip.So it made impossible to complete bone augmentation.There were no patient symptoms reported.There was a delay of 1 hour in overall procedure.The procedure was partially completed, it was impossible to inject cement during bone augmentation.Level implanted d10 ¿ d11¿ l1 ¿ l2.There were no further complications reported regarding the event.

• Brand Name: CD HORIZON® FENESTRATED SCREW SET
• Common Device Name: DISPENSER, CEMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 20006886
• Report Number: 1030489-2024-00993
• Device Sequence Number: 7201513
• Product Code: KIH
• UDI-Device Identifier: 00763000216740
• UDI-Public: 00763000216740
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2024

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: 6550041
• Device Catalogue Number: 6550041
• Device Lot Number: UNKNOWN
• 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: 07/22/2024
• Initial Report FDA Received Date: 08/20/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female