MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L DE C.V. KYPHON XPANDER INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number	K09A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2018
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 vertebral compression fractures (vcf) and underwent balloon kyphoplasty (bkp) surgery.During surgery, when the surgeon put the balloon into vertebral body and began inflating it, the balloon ruptured.No fragments of the alleged balloon remained in the patient.No patient symptoms or complication were reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: visual inspection did not reveal any visible damage to the shaft of the balloon of the ibt.Functional evaluation revealed that the bone tamp balloon will not inflate when injecting the ibt with fluid.The fluid would not pass through the shaft/tube to replicate the inflation of the balloon.Possible contrast left in tube causing the blockage.Root cause of the malfunction could not be determined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON XPANDER INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• 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: 8211242
• Report Number: 9612164-2019-00020
• Device Sequence Number: 2791593
• Product Code: HRX
• UDI-Device Identifier: 00858196001161
• UDI-Public: 00858196001161
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 02/17/2019

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: 01/25/2019
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 02/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR