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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
Device Problems Break (1069); Material Rupture (1546)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 11/21/2016
Event Type  Injury  
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 Description
It was reported that patient underwent balloon kyphoplasty for t9 vertebral body compression fracture. Intra-op, the balloon ruptured at 300psi and when the physician went to remove the balloon from the body, the balloon broke at distal end. Distal tip of inflatable bone tamp marker and a portion of balloon broke while trying to remove balloon from the cannula. As contrast blocked the view, sales rep thinks that the marker band at distal end of balloon was left in body and possibly part of balloon. No patient complications were reported. Patient was not allergic to the contrast media.
 
Manufacturer Narrative
Product analysis :the reported complaint of a balloon rupture was confirmed during product evaluation. A radial tear was observed near the distal peak of the balloon. This observation is consistent with rupture due to contact with bone splinters during instrument usage. Due to the ¿umbrella¿ effect of the radially cut ibt, the ibt was unable to be collapsed and removed from the stylus. The above observations are consistent with intraoperative instrument damage.
 
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Brand NameKYPHON EXPRESS INFLATABLE BONE TAMP
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
MDT KYPHON NEUCHATEL MFG
pierre-à-bot 97
neuchâtel,ne 2000
CH 2000
Manufacturer (Section G)
MDT KYPHON NEUCHATEL MFG
pierre-à-bot 97
neuchâtel,ne 2000
CH 2000
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key6180010
MDR Text Key62523780
Report Number2953769-2016-00088
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberKE152
Device Lot Number0008165201
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/16/2016 Patient Sequence Number: 1
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