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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
Device Problem Material Rupture (1546)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/10/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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
Pre-op diagnosis: compression fracture levels: th12 it was reported that on (b)(6) 2016, patient underwent balloon kyphoplasty. Intra-op, a balloon was caught on something during pulling out after deflating. A tip of balloon was broken because surgeon pulled out it forcibly. The surgeon tried to remove the balloon with a kocher but he could not. Cement was filled in the vertebral body and the surgery was finished. The surgeon said that they should have been careful when the balloon was caught on something during insertion. The surgeon commented that he considered there might have been something hard bone or pointed bone. During inserting the balloon into vertebral body, there was a low resistance. (there was no issue until passing through the osteointroducer. ) after the balloon was inflated/deflated at prepared hole (made with a drill), the balloon was stuck and broken. Curette was not used. No issue on opposite side was reported. The product was infected (unknown) and disposed at the hospital. Whether the fragments of the product remained inside the patient or not was unknown. Patient complications were reported unknown. The surgical time was extended less than 15 min. The fragment of balloon remained in the patient.
 
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Brand NameKYPHON XPANDER¿ 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)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5478960
MDR Text Key39632023
Report Number2953769-2016-00018
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,health
Reporter Occupation
Type of Report Initial
Report Date 02/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberK09A
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 Received02/10/2016
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: 03/04/2016 Patient Sequence Number: 1
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