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 09/13/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

Event Description

It was reported that on (b)(6) 2016, patient underwent balloon kyphoplasty at t12.Intra-op, the balloon ruptured while the surgeon was injecting the cement in the opposite working cannula.A bi-portal access with two balloons was performed.Surgeon inflated both the balloons at 350psi, after 2-3 minutes he deflated the balloon and started to fill up the cement, during which the controlateral balloon ruptured.The product came in contact of the patient.No patient complications were reported.

Manufacturer Narrative

Pma 510(k): this part is not approved for use in the united states; however a like device catalog # ke-152, 510k # k123771 was cleared in the united states.Product analysis: during functional analysis it was not possible to inflate the ibt due to a leak.Visual analysis confirmed the presence of longitudinal rupture near the proximal peak.Conclusion: based on the information provided, functional and visual analysis, the most probable root cause of the rupture of the balloon is attributed to contact with bone splinters during surgery.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

No fragments of the balloon remained inside the patient.

Manufacturer Narrative

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

• 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: 6019963
• MDR Text Key: 57061607
• Report Number: 2953769-2016-00080
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• 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: 0008050374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Is the Reporter a Health Professional?: No
• 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