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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY

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MEDTRONIC SOFAMOR DANEK USA, INC KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number C01B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Chest Tightness/Pressure (2463)
Event Date 04/17/2017
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. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient was pre-operatively diagnosed with vertebral compression fracture and underwent balloon kyphoplasty at t8. Post-operatively, the patient was presented to the emergency room with chest tightness. The ct scan was performed and the stated as micro embolism. There was no cement extravasation. The patient was asymptomatic. There was streaks of cement that showed up on the ct scan of the patient¿s lungs. Patient's issue was resolved.
 
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Brand NameKYPHON HV-R BONE CEMENT
Type of DeviceCEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key7518822
MDR Text Key108411243
Report Number1030489-2018-00710
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041584
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 05/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2020
Device Catalogue NumberC01B
Device Lot NumberWI501999
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 Received04/18/2018
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: 05/16/2018 Patient Sequence Number: 1
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