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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 K08A
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/18/2018
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.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that intra-operatively the ibt balloon rupture during inflation.The device came in contact with the patient.No patient complications were reported due to this event.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key7697632
Report Number2953769-2018-00021
Device Sequence Number11125977
Product Code HRX
UDI-Device Identifier00643169103054
UDI-Public00643169103054
Combination Product (Y/N)N
Initial Reporter CountryGM
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,Followup
Report Date (Section B) 10/04/2018
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 NumberK08A
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/18/2018
Supplement Date Received by Manufacturer08/08/2018
Initial Report FDA Received Date07/18/2018
Supplement Report FDA Received Date10/04/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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