MAUDE Adverse Event Report: MEDTRONIC MEXICO (TIJUANA) KYPHON XPANDER INFLATABLE BONE TAMP

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	11/09/2018
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 was pre-operatively diagnosed with primary osteoporosis (compression fracture) and underwent unspecified procedure.During the surgery, the balloon was inflated, and it was broken when approaching to the cortical bone of vertebral body.Since it was inflated to the targeted end point, the balloon was deflated, the contrast medium was removed from the patient body, the cement was injected and the procedure was completed successfully with the original product.The product came in contact with the patient.Patient complications were reported as unknown.
Additional Manufacturer Narrative
Additional info: product analysis: there is a cut in the balloon located on the proximal side of the peak circumference of the balloon.The cut runs perpendicular to the shaft of the inflatable bone tamp.This type of cut is usually caused by bones splinters.The fact that all three balloons have been cut int the same way and in approximately the same location points to sharp bone.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON XPANDER INFLATABLE BONE TAMP
• Common Device Name: TAMP
• Manufacturer (Section D): MEDTRONIC MEXICO (TIJUANA); avenida paseo cucapah # 10510; parque industrial ei lago; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 8144580
• Report Number: 9612164-2018-03519
• Device Sequence Number: 204130
• Product Code: HXG
• UDI-Device Identifier: 00643169103061
• UDI-Public: 00643169103061
• 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): 02/11/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1