MAUDE Adverse Event Report: MITG - TIJUANA KYPHON XPANDER¿ INFLATABLE BONE TAMP ARTHROSCOPE

Model Number KPT1502

Device Problems Material Deformation (2976); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2021

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

Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having l3bkp and 2a2b posterior fusion for primary osteoporosis with intravertebral cleft fracture. It was reported that it was difficult to insert ibt into osteo introducer.  an attempt was made to insert the balloon on one side into the osteo introducer, but the balloon didn't enter.  before the insertion, the white cover of the balloon was not removed according to the surgical technique.  an attempt was made to check the lubricant of the balloon outside the operative field, but they could not judge the presence or absence of the  lubricant because blood had already adhered.  even though negative pressure was applied again, the balloon still did not enter.  therefore, they swapped the left and right, removed the ibt that had already been placed in the vertebral body on the contralateral side, and inserted  it into the one that did not enter, but it was still difficult to enter, but they forced it in and placed the product in the vertebral body.  it was said that after the operation, the sales rep confirmed a scratch on the inner cylinder of the osteo introducer, so when looked inside the outer cylinder, it seemed that there was a burr. There was no patient symptom reported. There was a delay of less than 60 minutes. There were no further complications reported regarding the event.

• Brand Name: KYPHON XPANDER¿ INFLATABLE BONE TAMP
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MITG - TIJUANA; blvd. insurgentes parcela #37; tijuana, bc 22570 ; MX 22570
• Manufacturer (Section G): MITG - TIJUANA; blvd. insurgentes parcela #37; tijuana, bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12458851
• MDR Text Key: 272119586
• Report Number: 2936999-2021-00890
• 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: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: KPT1502
• Device Catalogue Number: KPT1502
• Device Lot Number: 221785907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial