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

Model Number	KR153
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Country: (b)(6).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 distributor regarding a patient with an unknown indication in need of spinal therapy.It was reported that the balloon breached and the t25r starting needle disturbed during the procedure.There were no patient symptoms reported.There were no fragments in the patient reported.There were no further complications reported regarding the event.
Event or Problem Description
Additional information received regarding the event.It was reported that the t25r needle bent and the balloon burst inside the vertebral body.The product came in contact with the patient.There was no delay in overall procedure time.Pre-op diagnosis: problem in the vertebral posture.Procedure involved: bilateral kyphoplasty with balloon.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Additional information: d9, h3, h6 h3.Device evaluation summary: visual and functional inspection revealed the balloon has been damaged.The balloon has a cut/slice near the center 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.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 ELEMENT 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: 10633099
• Report Number: 2953769-2020-00023
• Device Sequence Number: 3297466
• Product Code: HRX
• UDI-Device Identifier: 00643169582217
• UDI-Public: 00643169582217
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K151532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2021

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: 12/16/2020
• Device Model Number: KR153
• Device Catalogue Number: KR153
• Device Lot Number: 0009497400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 10/16/2020; 07/31/2021
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 11/02/2020; 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1