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	08/31/2017
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.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 patient with primary osteoporosis and compression fracture underwent balloon kyphoplasty at l3 level.On (b)(6) 2017, intra-operative, after inflating balloon, the anterior part of the balloon broke while waiting for the cement to harden.The bone spur was at the part where the balloon broke.Pressure prior to rupture is 200 psi.After that, the placement site was cleaned and filled with bone cement.It is unknown if patient is allergic to contrast media.It is unknown if any fragments of balloon remains inside patient.

• 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: 6896577
• Report Number: 2953769-2017-00100
• Device Sequence Number: 496636
• Product Code: HRX
• UDI-Device Identifier: 00643169103061
• UDI-Public: 00643169103061
• 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
• Report Date (Section B): 08/31/2017

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1