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

Catalog Number	K15B
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis :visual examination of the balloon appeared to be used but undamaged.Functional test: a sample syringe was filled with liquid, and then were injected into the returned ibt.The instrument was pressurized, with no leaks identified.Unable to replicate customer concern; after visual review and functional evaluation, no evidence was found that would suggest a defect in manufacturing or processing of the implant or associated components.The instrument appears to be capable of performing its intended function.
Event or Problem Description
It was reported that patient with compression fracture underwent balloon kyphoplasty at l2.Intra-op, after expansion, the balloon burst.It was lodged in the cannula.Physician had to remove cannula to remove the balloon.No patient complications were reported.

• Brand Name: KYPHON EXPRESS 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: 6375356
• Report Number: 2953769-2017-00017
• Device Sequence Number: 47360
• Product Code: HRX
• UDI-Device Identifier: 00613994721266
• UDI-Public: 00613994721266
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2017

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: K15B
• Device Lot Number: 0008107470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2017
• Initial Report FDA Received Date: 03/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1