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	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: visual and optical inspection revealed the balloon has been cut.The cut runs perpendicular to the shaft of the ibt.The morphology, location and timing of the balloon rupture is consistent with in-vivo contact with sharp object, such as bone splinters.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product was not 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
Type of fracture: compression fracture it was reported that the patient underwent balloon kyphoplasty due to adjacent vertebral fracture.Intra-op, the balloon ruptured during inflation.The pressure during rupture was about 160 psi.After that, the balloon that was on the contralateral side was reinserted and inflated.The contrast media inside the vertebral body was removed from the patient body by suction, and it was confirmed by the image there was no contrast media inside the vertebral body.Then, cement was filled and the operation was completed.The patient was not allergic to contrast media and no patient complications were reported.

• 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: 9364761
• Report Number: 9612164-2019-04868
• Device Sequence Number: 19361564
• 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,Followup
• Report Date (Section B): 03/12/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1