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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON EXPRESS II INFLATABLE BONE TAMP

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MEDTRONIC MEXICO KYPHON EXPRESS II INFLATABLE BONE TAMP Back to Search Results
Catalog Number KE152
Device Problem Deflation Problem (1149)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2020
Event Type  malfunction  
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 presented with vertebral compression fracture; and underwent balloon kyphoplasty. Intra op, the balloon inflated correctly but did not deflate properly. While removing the balloon from cannula, the balloon seemed to have stripped; and it was trouble getting the balloon out of the cannula. There was delay of about one minute due to this event in the overall procedure. No patient complications were reported.
 
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Brand NameKYPHON EXPRESS II INFLATABLE BONE TAMP
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer Contact
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key9683018
MDR Text Key191750302
Report Number9612164-2020-00620
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123771
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 02/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberKE152
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 Received01/15/2020
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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