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

Catalog Number K09A

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2020

Event Type  malfunction  

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 Description

Pre-operative diagnosis: primary osteoporosis type of fracture: compression fracture, large cleft on the left side of the vertebral body procedure: balloon kyphoplasty (bkp) levels implanted: th11 it was reported that intra-op, there was no problem with approaching and the balloons were expanded at a good position.The balloons were expanded for 2cc on both sides, and then, frontal image was checked.It was checked that there was still some room left up and down, left and right.And from this time, balloon expanding was performed for more 1cc and sagittal image was confirmed.It was checked for the last time that the balloons were in a good position, and the balloons have also united in the center.Bone cement was prepared.Cement was prepared and it was started to fill cement in with a good viscosity.When checking the image after deflating the balloon, it was found that although the balloon on the right side has been deflated, there was a little contrast media remaining.It was checked by using a confirmation syringe that blood was mixed there and the balloon had broken.When an attempt was made to remove the balloon, it seemed that the balloon had not cracked.Even when the balloon was deflated, a lot of blood had been contained, and contrast media transferred a little to the side of the image.Just in case, a thin tube was inserted to suck it out, but failed.It was also said by the surgeon that there would be no problem with this much, and cement filling was continued, and the operation was finished.When the broken balloon was expanded again after cement filling, a hole was found on the balloon, and it seemed that the leakage was from there.No fragment of the balloon remained inside the patient's body.There were no patient complications reported as a result of this event.

• Brand Name: KYPHON XPANDER INFLATABLE BONE TAMP
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9863823
• MDR Text Key: 193942499
• Report Number: 9612164-2020-01268
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: K09A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/22/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR