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

Catalog Number	KE102
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2018
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
It was reported that the patient was pre-operatively diagnosed with osteoporosis and underwent kyphoplasty at l2.During surgery, the balloon ruptured during inflation.Balloon pressure was said to be 200psi but volume was not able to be determined when the inflation syringe drew back to remove as much contrast as possible and then followed by an empty bone filler and 10 ml syringe to remove as much more as possible.The product came in contact with the patient.No patient complications were reported as result of the event.
Additional Manufacturer Narrative
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: 7676936
• Report Number: 1030489-2018-00978
• Device Sequence Number: 10963798
• Product Code: HRX
• UDI-Device Identifier: 00643169143791
• UDI-Public: 00643169143791
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/02/2018

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: KE102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR