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U.S. Department of Health and Human Services

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

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MEDTRONIC SOFAMOR DANEK KYPHON XPANDER INFLATABLE BONE TAMP ARTHROSCOPE Back to Search Results
Catalog Number K09A
Device Problem Material Rupture (1546)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/01/2018
Event Type  Injury  
Manufacturer Narrative
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 (bkp) due to primary osteoporosis, compression fracture. During the surgery, the ibt (inflatable bone tamp) ruptured at high pressure. The patient was not allergic to contrast media. When inserting the balloon, drilling could not be performed perfectly and the balloon on the right side could not enter. The balloon on the left side was set without problems. When drilling was performed on the right side, the balloon on the left side was not removed. And the balloon on the left side was broken due to drilling on the right side. The balloon's marker part remained in the patient¿s body. So it was removed as much as possible with the forceps from the gastric camera through the osteo introducer. Although the possibility that the balloon remained in the patient¿s body could not be denied, according to the judgment that it was removed successfully as much as possible, the cement was indwelt in the patient¿s body. The procedure was successfully completed with the original product. There was a delay of less than 60 minutes as a result of the event. No patient complications were reported as a result of the event.
 
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Brand NameKYPHON XPANDER INFLATABLE BONE TAMP
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key7365126
MDR Text Key103284307
Report Number1030489-2018-00446
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
Report Date 03/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberK09A
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 Received03/01/2018
Was Device Evaluated by Manufacturer? No
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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