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

Catalog Number	K15A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2020
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
Pre-operative diagnosis:compression fracture procedure: kyphoplasty levels treated : t8 intra-op, balloon popped(ruptured) while inflating in the patient¿s t8 vertebral body.The maximum volume was 2cc¿s with a pressure of 150psi.The procedure was successfully completed with the original product.There was no delay in overall procedure time.There were no patient symptoms or complications reported as a result of this event.

• Brand Name: KYPHON EXPRESS INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 10229109
• Report Number: 9612164-2020-02407
• Device Sequence Number: 3195069
• Product Code: HRX
• UDI-Device Identifier: 00763000025618
• UDI-Public: 00763000025618
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K041454
• 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): 07/03/2020

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: K15A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 07/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1