MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON EXPRESS II INFLATABLE BONE TAMP

Catalog Number	KE202
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2020
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 presented with l3 osteoporotic compression fracture due to vehicle accident; and underwent balloon kyphoplasty at l3.Intra-op, after gaining bipedicular access, both the balloons were inflated simultaneously.During inflation, the balloon ruptured at 270 psi.Volume prior to rupture was 4 cc.The patient was not allergic to contrast media.No patient complications were reported due to this event.

• Brand Name: KYPHON EXPRESS II INFLATABLE BONE TAMP
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 9620670
• Report Number: 9612164-2020-00382
• Device Sequence Number: 523947
• Product Code: HRX
• UDI-Device Identifier: 00763000025670
• UDI-Public: 00763000025670
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/23/2020

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: KE202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 99