MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L DE C.V. 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	01/31/2019
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
Type of fracture: compression fracture it was reported that the patient was pre-operatively diagnosed with primary osteoporosis and underwent balloon kyphoplasty.During the surgery, when inflating the balloon in the vertebral body, the balloon could not be inflated and because it was found that contrast medium leaked from the balloon.The balloon was ruptured and deformed.Another inflatable bone tamp was used to deal with it.Curette was not used.The product came in contact with the patient.Patient was not allergic to contrast media leak.No patient complications were reported as the result of the event.
Additional Manufacturer Narrative
Product analysis result: visual functional visual and optical inspection confirmed the balloon has been cut.The cut runs perpendicular to the shaft of the ibt.Functional check with a sample ibt syringe revealed the balloon would not inflate once the liquid was pushed into the ibt.This type of damage is consistent with the balloon coming in contact with 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 S. DE R.L DE C.V.; avenida paseo cucapah # 10510; parque industrial ei lago; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 8373285
• Report Number: 9612164-2019-00701
• Device Sequence Number: 16177918
• Product Code: HXG
• UDI-Device Identifier: 00613994703996
• UDI-Public: 00613994703996
• 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): 05/02/2019

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: 04/29/2019
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1