MAUDE Adverse Event Report: MEDTRONIC MEXICO 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	08/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Levels implanted: l4.It was reported that intra-operatively both the ibt balloon were ruptured during inflation at less than 100psi.The device came in contact with the patient.No patient complications were reported due to this event.

• Brand Name: KYPHON EXPRESS INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO; avenida paseo cucapah # 10510; parque industrial ei lago; tijuana,bc 2000 ; MX 2000
• MDR Report Key: 7825968
• Report Number: 2953769-2018-00026
• Device Sequence Number: 1287608
• Product Code: HRX
• UDI-Device Identifier: 00763000025625
• UDI-Public: 00763000025625
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 08/29/2018

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: K15B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1