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

Catalog Number	KX153
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis: vf (ventricular fibrillation).It was reported that intra-op, the surgeon used the balloon with 2.5ml of contrast product in the balloon.The balloon ruptured during inflation.The product came in contact with the patient.No patient complications occurred as a result of the event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Levels:l3 it was reported that no balloon fragments left in the patient.
Additional Manufacturer Narrative
A visual and functional review of the ibt reveal that the balloon has ruptured.The rupture is a radial rupture nearer to the distal peek.This type of rupture is consistent with the balloon coming in contact with bone splinters while in the vertebral body.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 2000 ; CH 2000
• MDR Report Key: 7006836
• Report Number: 2953769-2017-00114
• Device Sequence Number: 19170366
• Product Code: HRX
• UDI-Device Identifier: 00643169093652
• UDI-Public: 00643169093652
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101864
• 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,Followup
• Report Date (Section B): 05/29/2018

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: KX153
• Device Lot Number: 0008703601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 10/25/2017; 05/01/2018
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 11/20/2017; 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 77