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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
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/30/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of 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 patient with compression fracture underwent balloon kyphoplasty.During the surgery, the balloon ruptured during normal inflation.A curette was used.Patient was not allergic to contrast media.There was no patient complication reported for this event.
 
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Brand Name
KYPHON EXPRESS INFLATABLE BONE TAMP
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
MDT KYPHON NEUCHATEL MFG
pierre-à-bot 97
neuchâtel,ne 2000
CH  2000
MDR Report Key6776280
Report Number2953769-2017-00090
Device Sequence Number590473
Product Code HRX
UDI-Device Identifier00643169143777
UDI-Public00643169143777
Combination Product (Y/N)N
Initial Reporter StateRI
Initial Reporter CountryUS
PMA/510(K) Number
K123771
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/14/2017
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 NumberKE152
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/14/2017
Initial Report FDA Received Date08/09/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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