MAUDE Adverse Event Report: KYPHX® HV-R¿ BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Model Number C01A-J

Device Problems Coagulation in Device or Device Ingredient (1096); Failure to Eject (4010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

This product is not marketed in us but a similar device with product number c01a with 510(k)# k041584 and udi (b)(4) is marketed in us.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a distributor via a field contact regarding products used in bkp procedure for spinal therapy.It was reported that cement could not be filled smoothly from the mixer to the bfd.It was unknown which of the cement, mixer, and bfd was the cause.Initial reporter information and patient information cannot be provided due to the restriction by the privacy regulation.The reported products were replaced with the products of non-medtronic.Device status reason : never implanted the cement was solidified quickly.It was unknown if there was any malfunction with the mixer and kit.There was a delay in the procedure time.The procedure was completed successfully with other companies' products.The products did not come in contact with the patient.There were no patient symptoms/complications.Pre-operative diagnosis: vertebral fracture.Cement could not be injected from the mixer into bfd.It was said that it became difficult to inject from the second or third one.The alternative product was shipped, but it was said that the product became unclean and could not be used due to a customer's mishandling, so product of non-medtronic was used.The physician said that it had proceeded with the conventional procedure, but the cement could not be injected.There was a delay in the procedure of about 30 minutes.

Manufacturer Narrative

Product analysis: visual inspection confirmed the cement has been used and mixed in the mixer.Unable to determine consistency of cement at the time of mixing and use in the mixer tube.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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: KYPHX® HV-R¿ BONE CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• MDR Report Key: 11892000
• MDR Text Key: 252963091
• Report Number: 2953769-2021-00022
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C01A-J
• Device Catalogue Number: C01A-J
• Device Lot Number: EL70196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1