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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 No Known Impact Or Consequence To Patient (2692)
Event Date 09/13/2016
Event Type  malfunction  
Manufacturer Narrative
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 on (b)(6) 2016, patient underwent balloon kyphoplasty. Intra-op, balloon ruptured during deflation. The product came in contact with the patient. No fragments of the balloon remained inside the patient. No patient complications were reported.
 
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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)
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 Key6019960
MDR Text Key105920212
Report Number2953769-2016-00079
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
Report Date 09/13/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberK09A
Device Lot Number0008118775
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 Received09/13/2016
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

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