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

Catalog Number	KE152
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not 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
It was reported that the patient was pre-operatively diagnosed with fracture at l3 and underwent balloon kyphoplasty.Intra-op, the balloon ruptured while inflating.The ibt was filled to only 2.5 cc and the psi was about 250 when the balloon ruptured on the right side.The product came in contact with the patient.The patient was not allergic to the contrast media.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis- visual and functional review were performed.A visual and functional review of the ibt revealed that the balloon has ruptured.The balloon has ruptured close to the proximal peak and is a smaller rupture.The rupture is consistent with the balloon coming in contact with bone splinters while the balloon is inflated in the vertebral body.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON EXPRESS II INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 7333888
• Report Number: 1030489-2018-00374
• Device Sequence Number: 16250989
• Product Code: HRX
• UDI-Device Identifier: 00643169143777
• UDI-Public: 00643169143777
• 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,Followup
• Report Date (Section B): 05/11/2018

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: KE152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR