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

Model Number	KPT1002
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
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 healthcare professional via a manufacturer representative regarding a patient with pre-op diagnosis- primary osteoporosis, compression fracture involved in the balloon kyphoplasty procedure.It was reported that intra-operatively, due to the breakage of the 10m balloon, a new balloon kit was opened and inflated.The leaked contrast media was washed with saline as much as possible.Ibt ruptured during inflation.There was no patient symptom reported.There were no further complications reported regarding the event.There was no delay in overall procedure time.The procedure was performed successfully by using a new product.Patient was not hospitalized prolong as a result of this event.Event was associated with the patient.The reported product was discarded for the patient suspected of being infected.On 2022-feb-14, received additional information that contrast media leaked inside the patient's body, when cement was injected, the cement injection was not seen clear because of the leakage.This product came in contact with the patient.

• Brand Name: KYPHON XPANDER¿ INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13657982
• Report Number: 9612164-2022-00860
• Device Sequence Number: 5111496
• Product Code: HRX
• UDI-Device Identifier: 00763000031657
• UDI-Public: 00763000031657
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2022

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: 07/22/2023
• Device Model Number: KPT1002
• Device Catalogue Number: KPT1002
• Device Lot Number: 222890588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 03/03/2022
• Date Device Manufactured: 09/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 53 KG