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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHON XPANDER II INFLATABLE BONE TAMP; ARTHROSCOPE
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MDT KYPHON NEUCHATEL MFG KYPHON XPANDER II INFLATABLE BONE TAMP; ARTHROSCOPE Back to Search Results
Catalog Number KX103-C
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/10/2017
Type of Reportable Event Malfunction
Additional 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.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 or Problem Description
It was reported that intra-op, the balloon ruptured.After injecting 2ml of fluid into the balloon, the balloon lost pressure for a break in the membrane.There was a delay in the overall procedure time as a result of this event.However, the procedure was completed successfully with the original product.No patient complications were reported.
 
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Brand Name
KYPHON XPANDER II INFLATABLE BONE TAMP
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
MDT KYPHON NEUCHATEL MFG
pierre-à-bot 97
neuchâtel
CH 
MDR Report Key7011184
Report Number2953769-2017-00115
Device Sequence Number16254486
Product Code HRX
UDI-Device Identifier00643169093645
UDI-Public00643169093645
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K101864
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberKX103-C
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/11/2017
Initial Report FDA Received Date11/08/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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