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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO KYPHON INFLATABLE BONE TAMP ARTHROSCOPE Back to Search Results
Model Number KY_UNK_PLASTY
Device Problem Failure to Eject (4010)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/19/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Chalhoub g, cheung b, gonzalez c "balloon kyphoplasty complication: a case of a lodged balloon within the vertebral body. " cureus 12(9): e10542. (september 19, 2020). Doi 10. 7759/cureus. 10542 summary: balloon kyphoplasty (bkp) is a minimally invasive, percutaneous procedure used to restore vertebral body height and repair spinal compression fractures caused by osteoporosis. Bkp is indicated for acute symptomatic compression fractures with height loss of >20%. It is a type of vertebroplasty utilizing an inflatable bone tamp in the vertebral body to restore vertebral height prior to injection of bone cement. Similar to traditional vertebroplasty, bkp presents with many complications. Those complications include cement extravasation, thermal injury and post-procedural pain. However, bkp has been shown to be more effective at restoring vertebral height at lower pressures and with fewer complications than traditional vertebroplasty. Bkp has some complications specific to it, such as further vertebral fracture from balloon expansion, balloon rupture, and re-collapse following balloon deflation. This report describes a bkp in which the bone tamp broke off inside the patient and was unable to be removed, the first case of which to be described in the literature. Reported event: this report describes a case involving a balloon kyphoplasty bone tamp becoming lodged inside the vertebral body and unable to be withdrawn, the first report of its kind in the literature. A board certified interventional pain management physician was performing a balloon kyphoplasty for an l3 osteoporotic vertebral compression fracture using a bipedicular approach with two bone tamps. Cannulation and cavity formation were completed without complication; however, upon removal of the balloons it was noted that one had become lodged in the vertebral body. Several attempts were made to remove the balloon. Neurosurgery and the balloon manufacturer were consulted intraoperative, and it was decided to leave the balloon fragments in situ and complete the interventional fixation of the vertebral body with bone cement. The patient followed up in the clinic several months later without neurologic complications. Postoperative radiography confirmed the presence of a retained foreign body consistent with balloon fragments.
 
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Brand NameKYPHON 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 Key11567244
MDR Text Key242161054
Report Number9612164-2021-01145
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,litera
Reporter Occupation
Type of Report Initial
Report Date 03/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKY_UNK_PLASTY
Device Catalogue NumberKY_UNK_PLASTY
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2021
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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