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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 K09A
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/11/2017
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.
 
Event or Problem Description
It was reported that the patient underwent balloon kyphoplasty due to vertebral compression fracture.Intra op, balloon leakage was observed.There was contrast agent leakage.The balloon came in contact with the patient.Eventually the surgery was completed without the balloon.
 
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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 2000
CH  2000
MDR Report Key6847564
Report Number2953769-2017-00096
Device Sequence Number16301951
Product Code HRX
UDI-Device Identifier00643169103061
UDI-Public00643169103061
Combination Product (Y/N)N
Initial Reporter CountryCH
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) 08/11/2017
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 NumberK09A
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/11/2017
Initial Report FDA Received Date09/07/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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