MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON XPANDER¿ INFLATABLE BONE TAMP

Catalog Number	K09A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.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 primary osteoporosis and underwent balloon kyphoplasty (bkp) procedure at l1 level.During surgery, the balloon ruptured while inflating.The product came in contact with the patient.No fragment of the balloon remained in the patient.It was calculated that there was 3 ml of the contrast media remained in the patient.The patient was not allergic to contrast media.No patient complications were reported.

• Brand Name: KYPHON XPANDER¿ INFLATABLE BONE TAMP
• Common Device Name: TAMP
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7796422
• Report Number: 1030489-2018-01154
• Device Sequence Number: 19225919
• Product Code: HXG
• UDI-Device Identifier: 00858196001161
• UDI-Public: 00858196001161
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2018

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: K09A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1