MAUDE Adverse Event Report: MEDTRONIC MEXICO XPANDER II; ARTHROSCOPE

Model Number	KX203
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
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 field representative regarding patient with vertebral compression fracture l4 involved in the balloon kyphoplasty procedure.Levels implanted- l4.It was reported that intra-operatively, during inflation ibt ruptured at too low of a pressure and volume was used with analog atrion inflation syringe.Pressure prior to rupture 200ps.Balloon rupture at low pressure.There was no delay in overall procedure time.Patient was not hospitalized prolong as a result of this event.There were no patient symptoms or complications reported as a result of this event.Procedure was completed with original product.Patient is alive and no injury.

• Brand Name: XPANDER II
• 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: 13219834
• Report Number: 9612164-2022-00138
• Device Sequence Number: 17576291
• Product Code: HRX
• UDI-Device Identifier: 00763000311971
• UDI-Public: 00763000311971
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2022

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 Model Number: KX203
• Device Catalogue Number: KX203
• Device Lot Number: UNKNOWN
• 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: 12/16/2021
• Initial Report FDA Received Date: 01/11/2022
• 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: Unknown