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

Model Number	55850026540
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
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 percutaneous sp inal fixation for spinal fracture.It was reported that when the cement was ready to be used, the cement delivery guides with disposable tips were placed on the screws as per the surgical technique.The cement delivery device was then placed in the guide and the cement was delivered with the gun.Cement could not be visualized entering the vertebral body.The decision was made to move on to the next screw with similar results.The guides and tips were left in place for 3 min after cement delivery.When an attempt was made to remove the guides the tips were stuck in the head of the screws.While trying to remove the tips, it became clear that the cement did not go down the screw into the vertebral body, but spilled out into the head of the screws and around the screws. most of the cement ended up in the head of the screws and around the screw heads and had to be removed.Cement extravasation was detected intra-operatively.There was a delay to the total procedure time of more than 1 hour.The percutaneous procedure had to be changed mid case to a open procedure resulting in 2 long incisions and muscle disruption. there was no patient symptom reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
B2.Other: change of procedure from percutaneous procedure to an open procedure.H3.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 is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 17264452
• Report Number: 1030489-2023-00489
• Device Sequence Number: 7912341
• Product Code: PML
• UDI-Device Identifier: 00763000146160
• UDI-Public: 00763000146160
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2023

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: 55850026540
• Device Catalogue Number: 55850026540
• 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: 06/02/2023
• Initial Report FDA Received Date: 07/06/2023
• 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
• Patient Sex: Unknown