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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHOPAK¿ TRAY ARTHROSCOPE

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MDT KYPHON NEUCHATEL MFG KYPHOPAK¿ TRAY ARTHROSCOPE Back to Search Results
Catalog Number KPT1502
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Shock (2072)
Event Date 03/25/2016
Event Type  Death  
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. Although it is unknown if any medtronic devices contributed to the reported event, we are filing this mdr for notification purposes.
 
Event Description
It was reported that on 25-mar-2016 (approximately), the patient underwent balloon kyphoplasty procedure for compression fracture. Post-op, the patient was deceased. It was also reported that death occurred due to hemorrhagic shock due to excessive bleeding. The total amount of intra-op bleeding was reported to be 5600 cc, blood clotting was decreased. Unspecified other implants were also reported to be used in the surgery. The hospital considered the causal relationship between death and balloon kyphoplasty is not related due to massive loss of blood. They determined to perform surgery using instruments together to prevent complications as the patient had two locations of compression fractures, at thoracic and lumbar. No tumor was observed.
 
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Brand NameKYPHOPAK¿ TRAY
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 Key5684439
MDR Text Key46067023
Report Number2953769-2016-00039
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
Report Date 04/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberKPT1502
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 Received04/28/2016
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: 05/27/2016 Patient Sequence Number: 1
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