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

Model Number KPT1502

Device Problems Break (1069); Leak/Splash (1354)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care professional via manufacturer representative regarding a balloon used in kyphoplasty surgery.Pre-operative diagnosis for this procedure was primary osteoporosis and compression fracture.It was reported that during procedure the contrast media leaked during balloon inflation.It occurred after insertion into the vertebral body, removal and re-insertion.The balloon was inserted, removed and reinserted, and then the balloon broke.A new balloon was opened, and the procedure was continued.No patient symptoms reported.No further complications reported.

Manufacturer Narrative

H3: product analysis #261889210:part # kpt1502 lot # 220460942 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.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
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 10807437
• MDR Text Key: 215512182
• Report Number: 9612164-2020-04307
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K041454
• 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: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KPT1502
• Device Catalogue Number: KPT1502
• Device Lot Number: 220460942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR