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

Catalog Number	K09A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2019
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
It was reported that the patient underwent balloon kyphoplasty at l2.Intra-op, the balloon of the right side inflatable bone tamp (ibt) ruptured from the caudal side.The balloon inflated like the shape of an oblong cut in half although it was inflated from the center of the vertebral body.When it was considered that the balloon had inflated enough, the surgeon went to perform cement mixing.The pressure was about 160 psi at that time.During cement mixing, it was noticed that the pressure had become zero; hence, image confirmation was asked for.From the shape of the contrast media in the captured image, it was judged that the balloon ruptured.Without performing washing, the handle of the ibt syringe was pulled and the contrast media was sucked.As it became a level that was unable to be discriminated even with the images, the cement was filled and the operation was finished without any further problem.No fragment of the ruptured balloon remained inside the patient.There were no patient complications as a result of this event.

• 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
• MDR Report Key: 9211694
• Report Number: 9612164-2019-04424
• Device Sequence Number: 447812
• Product Code: HRX
• UDI-Device Identifier: 00763000025595
• UDI-Public: 00763000025595
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 10/19/2019

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 Catalogue Number: K09A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 10/19/2019
• 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