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

Catalog Number KX153-C

Device Problems Misconnection (1399); Material Puncture/Hole (1504); Packaging Problem (3007)

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

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog # kx153, 510k # k101864 and udi # (b)(4) was cleared in the united states.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

It was reported that the patient was diagnosed with compression fracture at l2; and underwent balloon kyphoplasty.Intra-op, while performing the procedure, the surgeon noticed a leakage on x-ray while he started to inflate balloons inside the patient vertebral body.When he tried to replace the balloon, all the available inflatable bone tamps (ibts) in the stock of the hospital were already pierced in the packaging.As all available ibts were defective, it was impossible to perform the planned balloon kyphoplasty.Hence, simple vertebroplasty was performed.No patient complications were reported due to this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

After the sales rep collected the alleged product from the hospital and checked the product himself, he found that the product was not defective at all.The inflatable bone tamp (ibt) worked pretty well.It was determined that the nurse had not connected the pump to the blue connector of the ibt; and instead, she removed the inner stylet of the ibt and plugged the pump on it.Because of this bad connection, she was unable to inflate the ibt and the water directly came out the edge of the ibt.The surgeon and the 'or' manager agreed with the sales rep's observation.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON XPANDER II 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: 9742900
• MDR Text Key: 188691350
• Report Number: 9612164-2020-00843
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: SEE H10
• 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,Followup,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2020
• Device Catalogue Number: KX153-C
• Device Lot Number: 0009487083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/13/2018
• 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 Outcome(s): Required Intervention