MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON XPEDE BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Model Number CX01B

Device Problem Leak/Splash (1354)

Patient Problems Extravasation (1842); No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

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.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional via manufacturer representative regarding bone cement used at adjacent level to multi-level fusion, to prevent adjacent level bone deterioration in patient.It was reported cement extravasations occurred in the patient and it was detected during procedure.Also, reported physician was advised to look lateral ap image, but ignored and continued the procedure.Physician implanted cement, it did not go into bone or pedicle.It was implanted lateral to the l1 body on the patients right (posterior), near the intervertebral foramen.There was delay in overall procedure time.Cement was stored at proper temperature(s) before and during the procedure and no malfunction of the cds system during use.Cement was mixed for 30 seconds, cured for 2.5 minutes.Cement was doughy and homogenous prior to delivery into the patient reported physician would monitor the patient for numbness in their inner thigh area or other adverse reactions.Patient is alive - no injury.

Event Description

Information was received from healthcare professional via manufacturer representative regarding bone cement used at adjacent level to multi-level fusion, to prevent adjacent level bone deterioration in patient.It was reported cement extravasations occurred in the patient and it was detected during procedure.Also, reported physician was advised to look lateral ap image, but ignored and continued the procedure.Physician implanted cement, it did not go into bone or pedicle.It was implanted lateral to the l1 body on the patients right (posterior), near the intervertebral foramen.There was delay in overall procedure time.Cement was stored at proper temperature(s) before and during the procedure and no malfunction of the cds system during use.Cement was mixed for 30 seconds, cured for 2.5 minutes.Cement was doughy and homogenous prior to delivery into the patient reported physician would monitor the patient for numbness in their inner thigh area or other adverse reactions.Patient is alive - no injury.On 2020-sep-25, received additional information that there is no patient symptoms or complications reported, patient is doing well.There is no additional treatment or surgery performed.There was delay in procedure for 15 minutes as they took multiple x-ray to verify extravasation.

Manufacturer Narrative

Additional information: h6: fdp code- c76143 applicable to the event.B5: updated with additional information.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: KYPHON XPEDE BONE CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10526827
• MDR Text Key: 206726767
• Report Number: 1030489-2020-01262
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 00643169097797
• UDI-Public: 00643169097797
• Combination Product (y/n): N
• PMA/PMN Number: K102397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: CX01B
• Device Catalogue Number: CX01B
• Device Lot Number: 0010309327
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1