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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHON XPANDER II INFLATABLE BONE TAMP0 ARTHROSCOPE

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MDT KYPHON NEUCHATEL MFG KYPHON XPANDER II INFLATABLE BONE TAMP0 ARTHROSCOPE Back to Search Results
Catalog Number KX203
Device Problem Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/30/2017
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. 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 Description
It was reported that the patient underwent balloon kyphoplasty surgery due to vetebral compression fractures. Intra-op, after deflating the balloon and removing through the introducer, the balloon itself detached from the shaft. Doctor had to pull very hard to get it out. The balloon remained inside the vertebral body (vb) with the cement. Doctor decided that it was related to how much hard the bone was inside the vb. No patient complication were reported as a result of this event. No additional surgery was performed to remove the balloon from the patient's body.
 
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Brand NameKYPHON XPANDER II INFLATABLE BONE TAMP0
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
MDT KYPHON NEUCHATEL MFG
pierre-à-bot 97
neuchâtel 2000
CH 2000
Manufacturer (Section G)
MDT KYPHON NEUCHATEL MFG
pierre-à-bot 97
neuchâtel 2000
CH 2000
Manufacturer Contact
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key7153720
MDR Text Key96001756
Report Number2953769-2017-00127
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberKX203
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2017
Was Device Evaluated by Manufacturer? No
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: 12/28/2017 Patient Sequence Number: 1
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