MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON EXPRESS¿ II INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number	KEX152EB-CDS-
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis results: visual and optical inspection confirmed the ibt was returned still stuck in the stylus/trocar.Optical inspection of the tip of the ibt did not reveal any damage that could contribute to the balloon rupture.The balloon may have come in contact with a bone splinter while in the vertebral body.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent spinal surgery due to vertebral compression fracture.Intra-op, the ibt ruptured.The balloon folded in on itself and became stuck on the trocar preventing removal.The entire trocar had to be removed and the deformed balloon needed to be sequentially pulled with a kelley clamp to remove it from the trocar tract out of the patient.The rupture initially occurred with minimal exposure to cement using the cement resistance technique.Contact time was less than 30 seconds.There were no patient symptoms or complications as a result of this event.

• Brand Name: KYPHON EXPRESS¿ II INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 9289068
• Report Number: 1030489-2019-01285
• Device Sequence Number: 2104089
• Product Code: HRX
• UDI-Device Identifier: 00643169671645
• UDI-Public: 00643169671645
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K123771
• 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): 11/07/2019

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 Expiration Date: 06/06/2020
• Device Catalogue Number: KEX152EB-CDS-
• Device Lot Number: 0009836697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1