MAUDE Adverse Event Report: WARSAW ORTHOPEDIC, INC. CD HORIZON® FENESTRATED SCREW SET; DISPENSER, CEMENT

Model Number	6550202
Medical Device Problem Codes	Leak/Splash (1354); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from multiple sources (healthcare provider, distributor) regarding a fns tip used on patient having spinal therapy.It was reported that there was a leak during injecting the cement with screws while using the fns tip during a fixation spine-cemented screws implantation procedure.Patient symptoms were unknown.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
G2: country of event: jordon.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 received that pre-op for the patient was compression fracture and osteoporosis.12 pedicle screws was used to stabilize the lumbar segment from l1 to s1.Following cement delivery and removal of the delivery guide, cement leakage observed at all 12 screw sites.The cement extravasated onto the screw heads, causing the delivery tips to adhere to the screw heads.Additionally, an insufficient amount of cement was delivered into the pedicles, which resulted in the team spending over an hour carefully removing the leaked cement and detaching the delivery tips.The patient's condition had remained stable with no complications reported.The doctor decided to extend the patient's stay in hospital for more investigations and assessment; a ct scan had been done to make sure that everything was done well.
Additional Manufacturer Narrative
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® FENESTRATED SCREW SET
• Common Device Name: DISPENSER, CEMENT
• Manufacturer (Section D): WARSAW ORTHOPEDIC, INC.; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDIC, INC.; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 22902204
• Report Number: 1824199-2025-00031
• Device Sequence Number: 8932065
• Product Code: KIH
• UDI-Device Identifier: 00763000211035
• UDI-Public: (01)00763000211035(17)320529(10)H5956314
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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: 6550202
• Device Catalogue Number: 6550202
• Device Lot Number: H5956314
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/19/2025
• Date Device Manufactured: 05/29/2024
• 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
• Patient Age: 68 YR
• Patient Sex: Female