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

Catalog Number	K13A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/24/2017
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.
Event or Problem Description
It was reported that patient with primary osteoporosis and compression fracture underwent kyphoplasty.Intra-op, contrast media leaked from the area where the stylet was pulled out of the inflatable bone tamp (ibt).Reportedly,balloons were inflated to 1.5ml on the both sides of vertebral body using lateral image.When the balloons were confirmed by front image, stylet of ibt was pulled out.At the time of adding inflation of balloon, contrast media leaked from the area where the stylet was pulled out.The surgeon stopped the inflation and removed the balloon placed at left side.The surgeon checked the balloon for damage outside the surgical field.It was judged that the balloon was not broken because it could not be inflated under the condition that the stylet was pulled out but it could be inflated with the stylet inserted.The surgeon decided to use the balloon used on the right side to the left side.When image was changed to the lateral image, and right side of ibt stylet was pulled out, contrast media leaked same as that happening on the left side.The left side of balloon was tried to be inflated under the condition that stylet was inserted but the patient¿s bone was hard, so that it could not be inflated.As a result, cement was filled in only the right side and the incision was closed.It seemed that tip of the stylet might have broken the balloons from the inside.The procedure was completed with the original product.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
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: 6423440
• Report Number: 2953769-2017-00023
• Device Sequence Number: 603264
• Product Code: HRX
• UDI-Device Identifier: 00858196001178
• UDI-Public: 00858196001178
• 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): 02/24/2017

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: K13A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2017
• Supplement Date Received by Manufacturer: 02/24/2017
• Initial Report FDA Received Date: 03/22/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1