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

Catalog Number	KX203
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were 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 osteoporotic vertebral fractures underwent balloon kyphoplasty in lumbar region.Intra-op, the balloon plastic and metal tip stuck in the vertebral body.The balloon plastic was torn apart while trying to remove the balloon from the vertebral body.The metal tip of the balloon stayed stuck in the vertebrae.No patient complications were reported.
Additional Manufacturer Narrative
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: 6325030
• Report Number: 2953769-2017-00012
• Device Sequence Number: 13729607
• Product Code: HRX
• UDI-Device Identifier: 00643169093676
• UDI-Public: 00643169093676
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K101864
• 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,Followup
• Report Date (Section B): 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: KX203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2017
• Supplement Date Received by Manufacturer: 01/18/2017
• Initial Report FDA Received Date: 02/12/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other