MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV KYPHOPAK EXPRESS TRAY; ARTHROSCOPE

Model Number	KPE1001
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2020
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 device used for spinal therapy.It was reported that intra-op, balloon immediately ruptured upon the inflation process.While performing kyphoplasty, inflation balloon leaked.Dye was injected into the balloon and 2ml leaked into operative site within patient.Doctor immediately withdrew device, and cleaned area with saline, and withdraw the dye.There was no harm to the patient, and the care finished without additional incident.
Additional Manufacturer Narrative
H3: product analysis #visual and functional inspection revealed the balloon has been damaged.The damage is a pinhole in the lower portion of the balloon.This type of damage is consistent with the balloon coming in contact with bone spurs when the balloon is inflated in the vertebral body.H6: fdm and fdr codes updated as per new 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.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: KYPHOPAK EXPRESS TRAY
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• MDR Report Key: 10860180
• Report Number: 9617601-2020-00017
• Device Sequence Number: 11422093
• Product Code: HRX
• UDI-Device Identifier: 00763000031800
• UDI-Public: 00763000031800
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K041454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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: 04/25/2021
• Device Model Number: KPE1001
• Device Catalogue Number: KPE1001
• Device Lot Number: 217765538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1