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

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	08/22/2019
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 for this procedure: primary osteoporosis type of fracture: compression fracture type of procedure: balloon kyphoplasty levels implanted: th11 it was reported that intra-op, as the balloon inflated into an oval shape, a curette was used after the balloon was removed.Even after using the curette, the balloon did not inflate properly, but it was continued to prepare the bone cement.When the balloon was confirmed by the image at the time of checking viscosity of the cement, a shadow as if showing that the contrast medium had leaked was seen.So, the balloon was deflated and removed.It was also confirmed outside the operative field that the balloon had ruptured.It was determined that the balloon ruptured at high pressure.After washing, the surgeon continued the operation.Bone cement was filled in the cavity which was created and then wound closure was performed.The patient was not allergic to contrast media.No fragment of the ruptured balloon remained inside the patient.There were no patient complications reported as a result of this event.

• Brand Name: KYPHON XPANDER 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: 9101832
• Report Number: 9612164-2019-04006
• Device Sequence Number: 14249460
• Product Code: HRX
• UDI-Device Identifier: 00763000025595
• UDI-Public: 00763000025595
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2019

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: 08/22/2019
• Initial Report FDA Received Date: 09/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR