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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHON XPANDER INFLATABLE BONE TAMP; ARTHROSCOPE
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MDT KYPHON NEUCHATEL MFG KYPHON XPANDER INFLATABLE BONE TAMP; ARTHROSCOPE Back to Search Results
Catalog Number K13A
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/10/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported event.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Pre-operative diagnosis: primary osteoporosis procedure: balloon kyphoplasty it was reported that during inflation of balloon, the balloon ruptured at about 250psi, there was a delay of less than 60 minutes in the overall procedure time as a result of this event.The product came in contact with the patient.The procedure was completed successfully with a new product.No patient complications were reported.
 
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Brand Name
KYPHON XPANDER 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 Key7497823
Report Number1030489-2018-00649
Device Sequence Number19261950
Product Code HRX
UDI-Device Identifier00643169103078
UDI-Public00643169103078
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K041454
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) 05/09/2018
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 NumberK13A
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/10/2018
Initial Report FDA Received Date05/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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