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U.S. Department of Health and Human Services

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

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MDT KYPHON NEUCHATEL MFG KYPHON® EXPRESS¿ INFLATABLE BONE TAMP ARTHROSCOPE Back to Search Results
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
If information is provided in the future, a supplemental report will be issued.
 
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.
 
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Brand NameKYPHON® EXPRESS¿ INFLATABLE BONE TAMP
Type of DeviceARTHROSCOPE
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 Key6019963
MDR Text Key105918614
Report Number2953769-2016-00080
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberKE152-INT
Device Lot Number0008050374
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2016
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

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