MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® FENESTRATED SCREW SET; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	55750026545
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional information was received via manufacturer representative that the leaked cement caused a pulmonary embolism.There were no problems with the handling of the cement even it was not stored according to appropriate temperature.There is no revision surgery scheduled or planned for the removal of implanted product and no malfunction associated with mdt mixer.There were no problems with the filled cement and hence this event occurred during normal use of products and no suspected manufacturing issue.The cement did not back-flowed from screw head.It is believed that the cement was injected through a normal horizontal hole and entered the blood vessel.
Additional Manufacturer Narrative
B5 has been updated.Radiographic image review: lateral fluro multiple pedicle screws are present.Unable to count levels.Cement augmentation present at each level possible extravasation at l1 and th11 is seen.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
B2: other - patient had pulmonary embolism.G2: country of origin is japan.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 via healthcare provider (hcp) via manufacturer representative regarding product used in balloon kyphoplasty (bkp) procedure for multiple myeloma.Type of fracture was compression fracture.Level at which implant was performed is t11/l2 (l1bkp) and l4bkp.It was reported that balloon alone was used in l4.L1 was fixed with 2a-1b after performing bkp.Fns was used for t11/t12/l2, and normal screws were inserted into l1.It was observed that there was cement extravasation and patient had pulmonary embolism which resulted in hospitalization or prolongation of hospitalization.It was also said that cement was not stored according to appropriate temperature.There were no further complications or symptoms reported.Additional information was received via manufacturer representative that during the procedure, cement leakage was not noticed, but it was discovered in postoperative examinations.Leakage appeared to occur from the screw on the right side of th11.It is now asymptomatic, with no health damage and will be monitored through appropriate conservative treatment.Additional information was received via manufacturer representative that the leaked cement caused a pulmonary embolism.There were no problems with the handling of the cement even it was not stored according to appropriate temperature.There is no revision surgery scheduled or planned for the removal of implanted product and no malfunction associated with mdt mixer.There were no problems with the filled cement and hence this event occurred during normal use of products and no suspected manufacturing issue.

• Brand Name: CD HORIZON® FENESTRATED SCREW SET
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• 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: 21736578
• Report Number: 1030489-2025-01584
• Device Sequence Number: 8626591
• Product Code: PML
• UDI-Device Identifier: 00763000148836
• UDI-Public: 00763000148836
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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: 55750026545
• Device Catalogue Number: 55750026545
• Device Lot Number: H5775420
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/24/2025
• Date Device Manufactured: 07/13/2022
• 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: Other; Hospitalization
• Patient Sex: Unknown