MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHON® EXPRESS¿ INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number KE152-INT

Device Problem Material Rupture (1546)

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

Event Date 09/01/2016

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.

Event Description

It was reported that on (b)(6) 2016, patient underwent balloon kyphoplasty.Intra-op, balloon ruptured during inflation.Procedure was performed at 4 levels, while performing procedure at 3rd level 3 balloon got a hole.The product came in contact with the patient.No patient complications were reported.

Manufacturer Narrative

Additional information: product analysis: during functional analysis, it was not more possible to inflate the balloon due to a leak/hole on the ibt.Visual analysis confirmed that there is a longitudinal rupture near the distal peak of the ibt.Conclusion:based on the information provided, visual and functional analysis, the most probable root cause of the rupture of the balloon is attributed to the contact with bone splinters during surgery.

• Brand Name: KYPHON® EXPRESS¿ 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): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel,ne 2000 ; CH 2000
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5986218
• MDR Text Key: 55877284
• Report Number: 2953769-2016-00075
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KE152-INT
• Device Lot Number: 0008105538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2016
• 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
• Patient Sequence Number: 1