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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO (TIJUANA) KYPHON XPANDER INFLATABLE BONE TAMP ARTHROSCOPE Back to Search Results
Catalog Number K08A
Device Problem Deflation Problem (1149)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/01/2018
Event Type  Injury  
Manufacturer Narrative
Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient underwent kyphoplasty at l3 due to vertebral compression fracture. Intra-op, when time came to remove balloon from vertebral body the balloon would not deflate. The surgeon deflated the balloon using a long needle to puncture balloon. When the surgeon attempted to remove the balloon, part between radiopaque markers broke off from the shaft of the balloon leaving that part in vertebral body. The surgeon proceeded to stabilize body with cement. The procedure was successfully completed with the original product. As per the surgeon, the patient was ok after the procedure.
 
Manufacturer Narrative
Visual examination of the ibt confirmed the expandable balloon has been pulled away from the tube/shaft on the ibt and the other still has the balloon attached. It appears the tube/shaft the ibt has been cut in half due to some complications during surgery. Product cannot be functionally tested/analyzed in the returned state. The root cause of failure and damage is unknown. 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 (TIJUANA)
avenida paseo cucapah # 10510
parque industrial ei lago
tijuana,bc TN 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO (TIJUANA)
avenida paseo cucapah # 10510
parque industrial ei lago
tijuana,bc TN 22570
MX 22570
Manufacturer Contact
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key7640503
MDR Text Key112410551
Report Number1030489-2018-00912
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberK08A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2018
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

Patient Treatment Data
Date Received: 06/27/2018 Patient Sequence Number: 1
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