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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG ARTHROSCOPE

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MDT KYPHON NEUCHATEL MFG ARTHROSCOPE Back to Search Results
Catalog Number K09A
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/20/2017
Event Type  Injury  
Manufacturer Narrative
Product analysis: on the ibt, there is a tear around the entire circumference of the balloon ~5mm from the tip of the balloon. Given the damage is all the way around the balloon the damage could have happened while being pulled back through the cannula. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product image review: submitted images appear to display ruptured ibt. If information is provided in the future, a supplemental report will be issued.
 
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 with primary osteoporosis and compression fracture underwent balloon kyphoplasty. Intra-op, the metal fragment of inflatable bone tamp remained in the patient's body but cement was injected. Whole balloon parts came off, but cement was inserted to the balloon. Patient complications reported as unknown.
 
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Type of DeviceARTHROSCOPE
Manufacturer (Section D)
MDT KYPHON NEUCHATEL MFG
pierre-à-bot 97
neuchâtel TN 2000
CH 2000
Manufacturer (Section G)
MDT KYPHON NEUCHATEL MFG
pierre-à-bot 97
neuchâtel TN 2000
CH 2000
Manufacturer Contact
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key6957277
MDR Text Key100587637
Report Number1030489-2017-02223
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K041454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberK09A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2018
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: 10/18/2017 Patient Sequence Number: 1
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