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

Catalog Number	K15A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2017
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 vertebral compression fracture of the underwent kyphoplasty.Intra-op, the balloon ruptured in the vertebral body during deflation.The surgeon left the balloon in the bone while waiting for the cement to be ready for implantation, and the balloon popped.All the fragments of the ruptured balloon were removed from the patient.No patient complications were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON EXPRESS INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel 2000 ; CH 2000
• MDR Report Key: 6306291
• Report Number: 2953769-2017-00010
• Device Sequence Number: 13561315
• Product Code: HRX
• UDI-Device Identifier: 00858196001185
• UDI-Public: 00858196001185
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 01/11/2017

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: K15A
• Device Lot Number: 0008166852
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: 01/11/2017
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1