MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHON XPANDER II INFLATABLE BONE TAMP

Catalog Number	KX153-C
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/19/2017
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.Product image review: submitted images appear to display instrument tip puncture.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 during the surgery, after the balloon was inserted in the patient through the trocar, the surgeon wanted to dilate the balloon but there was no reaction of the balloon via x-ray to see.So the balloon was put out and checked with water and a hole was noticed at the tip of the balloon.

• Brand Name: KYPHON XPANDER II INFLATABLE BONE TAMP
• Common Device Name: TAMP
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel ; CH
• MDR Report Key: 6871540
• Report Number: 2953769-2017-00097
• Device Sequence Number: 566716
• Product Code: HXG
• UDI-Device Identifier: 00643169093652
• UDI-Public: 00643169093652
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101864
• 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
• Report Date (Section B): 08/21/2017

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: KX153-C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 09/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1