MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHON XPANDER¿ INFLATABLE BONE TAMP ARTHROSCOPE

Catalog Number K09A

Device Problem Material Rupture (1546)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4). 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.

Event Description

Pre-op diagnosis: compression fracture levels: th12 it was reported that on (b)(6) 2016, patient underwent balloon kyphoplasty. Intra-op, a balloon was caught on something during pulling out after deflating. A tip of balloon was broken because surgeon pulled out it forcibly. The surgeon tried to remove the balloon with a kocher but he could not. Cement was filled in the vertebral body and the surgery was finished. The surgeon said that they should have been careful when the balloon was caught on something during insertion. The surgeon commented that he considered there might have been something hard bone or pointed bone. During inserting the balloon into vertebral body, there was a low resistance. (there was no issue until passing through the osteointroducer. ) after the balloon was inflated/deflated at prepared hole (made with a drill), the balloon was stuck and broken. Curette was not used. No issue on opposite side was reported. The product was infected (unknown) and disposed at the hospital. Whether the fragments of the product remained inside the patient or not was unknown. Patient complications were reported unknown. The surgical time was extended less than 15 min. The fragment of balloon remained in the patient.

• Brand Name: KYPHON XPANDER¿ INFLATABLE BONE TAMP
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel,ne 2000 ; CH 2000
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5478960
• MDR Text Key: 39632023
• Report Number: 2953769-2016-00018
• 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,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: K09A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/10/2016
• 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 Treatment Data

Date Received: 03/04/2016 Patient Sequence Number: 1