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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO KYPHON EXPRESS II INFLATABLE BONE TAMP ARTHROSCOPE Back to Search Results
Model Number KE152
Device Problem Material Rupture (1546)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/04/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from healthcare professional via field representative regarding patient with vertebral compression fracture thoracic involved in eggshell technique/ kyphoplasty procedure. Levels implanted-t-12. It was reported that during procedure, while attempting eggshell technique, ibt ruptured. Part of the balloon with radiopaque markers remains in the vertebral body. Ibt ruptured during inflation. Patient was not allergic to the contrast media. There was no delay in overall procedure time. Patient was not hospitalized prolong as a result of the event. There were no patient symptoms or complications reported as a result of this event. There was no additional treatment/surgery performed as a result of this event. There is no revision surgery planned. Patient is alive and no injury.
 
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Brand NameKYPHON EXPRESS II 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
tricha miles
1800 pyramid place
memphis, TN 38132
7635140379
MDR Report Key11377301
MDR Text Key233441257
Report Number9612164-2021-00773
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,Followup,Followup
Report Date 04/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKE152
Device Catalogue NumberKE152
Device Lot NumberUNKNOWN
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 Received04/14/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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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