MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHON XPANDER INFLATABLE BONE TAMP; ARTHROSCOPE

Model Number	K09A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2020
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
Pre op diagnosis: osteoporotic compression fractured procedure performed: kyphoplasty with bilateral balloon distraction intra op, after the working access was established, it was planned that the two balloons were simultaneously deployed, but both of the balloons appeared to be in a state of pressure loss, and there was a contrast agent in the vertebral body during the surgery.After implantation, it was pressurized with a pressure pump, but the balloon could not be opened and there was a contrast agent in the vertebra.After the balloon was removed, it was found that the balloon was damaged and the contrast agent was leaking.There was a delay of one hour.After the balloon was removed, the pressure pump was used in vitro to open the balloon.It was found that the contrast agent was sprayed at the root of the connection between the balloon body and the balloon rod.There were no complications to the patient as a result of this event.
Additional Manufacturer Narrative
H3.Device evaluation summary: visual and optical inspection revealed some damage to the upper shaft but none on the balloon of the ibt.Functional inspection with a sample syringe confirmed the tip of the balloon was leaking.It appears inner metal shaft/wire of the ibt has been pushed through the balloon causing the leak when pressurized.This type of damage is consistent with excessive force when inserting the ibt through the cannula.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: KYPHON XPANDER INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel 2000 ; CH 2000
• MDR Report Key: 10231460
• Report Number: 2953769-2020-00011
• Device Sequence Number: 11369127
• Product Code: HRX
• UDI-Device Identifier: 00643169103061
• UDI-Public: 00643169103061
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K041454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2020

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: 06/26/2020
• Device Model Number: K09A
• Device Catalogue Number: K09A
• Device Lot Number: 0009216588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 09/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 75