MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON XPANDER II INFLATABLE BONE TAMP; ARTHROSCOPE

Model Number	KPX153RB
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Information was received from a healthcare provider via a manufacturer representative regarding a patient with with an unknown indication for spinal therapy.It was reported that intra-op, ibt fail occur during the first attempt.During inflation, one balloon had a leak of contrast and the other one broke at 150 psi.Ibt fail during the first insertion attempt into the vertebral body there was a delay in overall procedure time.Further there were no patient symptoms or complications as a result of this event.
Additional Manufacturer Narrative
H6: fdm,fdr and imf codes updated as per new information.B5,b7: additional information received.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.
Event or Problem Description
It was reported that there was no delay in the procedure.The product will not be returned.Pre-operative diagnosis: vertebral facture due to compression.Tumor located in t11.

• Brand Name: KYPHON XPANDER II INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 11064121
• Report Number: 9612164-2020-05040
• Device Sequence Number: 11413589
• Product Code: HRX
• UDI-Device Identifier: 00763000031589
• UDI-Public: 00763000031589
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K101864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/22/2021
• Device Model Number: KPX153RB
• Device Catalogue Number: KPX153RB
• Device Lot Number: 220822330
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1