MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG 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	01/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned to manufacturer for evaluation; therefore, we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that patient with primary osteoporosis and compression fracture underwent balloon kyphoplasty at th12.Intra-op, while placing the balloon, ibt(inflatable bone tamp) ruptured.The procedure completed with the original product.The patient was not allergic to contrast media.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: functional evaluation of the ibt balloon identified a sharp cut at the balloon, disallowing inflation.The morphology, location and timing of the balloon rupture is consistent with in vivo contact with sharp object, such as bone splinters.

• 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: 6335116
• Report Number: 2953769-2017-00014
• Device Sequence Number: 1709942
• Product Code: HRX
• 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): 03/23/2017

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: K09A
• Device Lot Number: 0008228431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/22/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 03/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1