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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 Material Integrity Problem (2978)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/11/2019
Event Type  Injury  
Manufacturer Narrative
Device fragment in patient. 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 underwent balloon kyphoplasty due to osteoporotic spinal fracture of t12 and l1. Intra-op, the left inflatable bone tamp (ibt) of l1 inflated in a vertical snowman shape that pushed up the superior endplate. Then, the surgeon deflated it and waited for the contrast to come into the inflation syringe, but the surgeon struggled to extract it. It was noted that the wire came loose and pulled away from the back of the balloon but when he tried to push it forward, it wouldn't budge. Then surgeon pulled hard and the ibt came out but the silicone piece of the balloon was left behind in the patient's vertebral body. The balloon ruptured during deflation when the pressure was less than 200 psi and volume of rupture was 3 cc. The surgeon cemented the broken fragment of the balloon in place. Cement was injected and the procedure was completed successfully. No patient complications have been reported.
 
Manufacturer Narrative
Product analysis: visual inspection confirmed the balloon and part of the plastic sleeve has been torn from the shaft of the ibt. It appears the ibt was damaged from the removal process. It was unable to determine root cause of ibt damage. T. 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 Key9175746
MDR Text Key162622375
Report Number9612164-2019-04303
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 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberK09A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2019
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

Patient Treatment Data
Date Received: 10/10/2019 Patient Sequence Number: 1
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