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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON XPANDER INFLATABLE BONE TAMP ARTHROSCOPE

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MEDTRONIC MEXICO KYPHON XPANDER INFLATABLE BONE TAMP ARTHROSCOPE Back to Search Results
Catalog Number K09A
Device Problem Deflation Problem (1149)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/24/2019
Event Type  malfunction  
Manufacturer Narrative
Product was not 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
Pre-operative diagnosis: primary osteoporosis type of fracture: compression fracture it was reported that intra op, after balloon inflation, when the surgeon tried to deflate it, it could not be deflated even when the handle of the inflation syringe was pulled. The balloon could still not be deflated when the surgeon removed the inflation syringe from the inflatable bone tamp (ibt). Then the locking syringe was attached to the ibt and locking syringe was used instead to suck the contrast media, but the balloon did not deflate. So, the balloon was removed by force. It is said that the balloon among the returned items was in a half inflated state. The procedure was however completed successfully with the same product; and no patient complications were reported due to this event. In the sales rep opinion, probably the product was used without the stylet.
 
Manufacturer Narrative
Product analysis: visual and functional inspection confirmed the ibt balloon was deformed and three syringe had dried contrast in the tube. Functional inspection confirmed the syringe would not pass any liquid due to the dried contrast in the lines and the balloon would inflate but very slowly. The shape of the inflated balloon was abnormal. It was unable to determine root cause of the non-conformance. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameKYPHON XPANDER INFLATABLE BONE TAMP
Type of DeviceARTHROSCOPE
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 Key9226700
MDR Text Key164466741
Report Number9612164-2019-04480
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 12/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberK09A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2019
Was Device Evaluated by Manufacturer? Yes
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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