MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHON XPANDER¿ INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number	K08A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2017
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.A good faith effort will be made to obtain the applicable information relevant to the report.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 (bkp) at l3 due to vertebral fracture.During the surgery, at the pressure of 220 psi the balloon burst.No fragment of the balloon remained in the patient.No patient complications were reported as the result of this event.The patient was not allergic to contrast medium.The procedure was completed successfully with the original product.
Additional Manufacturer Narrative
Evaluation results: product analysis: during functional analysis, it was not more possible to inflate the balloon due to a hole or leak.During visual analysis, the presence of a hole in the balloon was confirmed.There was a radial rupture on the distal peak of the ibt.Based on the information provided, visual and functional analysis, the most probable root cause of the rupture of the balloon could attributed to contact with bone splinters during surgery.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): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel,ne 2000 ; CH 2000
• MDR Report Key: 6899941
• Report Number: 2953769-2017-00102
• Device Sequence Number: 16439555
• Product Code: HRX
• UDI-Device Identifier: 00643169103054
• UDI-Public: 00643169103054
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/22/2017

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: K08A
• Device Lot Number: 0008678937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Initial Date Received by Manufacturer: 09/04/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1