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

Catalog Number	KX203
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that patient with fracture at "bwk 11" underwent balloon kyphoplasty.Intra-op, the balloon burst while inflating.No patient complications were reported.Patient was not allergic to contrast media.
Additional Manufacturer Narrative
Device evaluation: there is a cut in the balloon running parallel with the ibt shaft.This type of damage is consistent with the balloon coming in contact with bone during inflation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON XPANDER II 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: 6953931
• Report Number: 2953769-2017-00107
• Device Sequence Number: 13760288
• Product Code: HRX
• UDI-Device Identifier: 00643169093676
• UDI-Public: 00643169093676
• 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,Followup
• Report Date (Section B): 04/16/2018

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: KX203
• Device Lot Number: 0008726295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1