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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L DE C.V. KYPHON XPANDER INFLATABLE BONE TAMP ARTHROSCOPE

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MEDTRONIC MEXICO S. DE R.L DE C.V. KYPHON XPANDER INFLATABLE BONE TAMP ARTHROSCOPE Back to Search Results
Catalog Number K09A
Device Problem Deflation Problem (1149)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/29/2019
Event Type  malfunction  
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 was pre-operatively diagnosed with compression fracture of the vertebrae and underwent balloon kyphoplasty (bkp) procedure. During surgery, the balloon could not deflate. The balloon was inflated till 140 psi pressure after which the deflation issue occurred. The product came in contact with the patient. No patient complications were reported.
 
Manufacturer Narrative
Product analysis result: visual functional visual inspection reveal one of the ibt had a small pin hole at the tip and the other ibt has been completely torn off. Functional check with a sample syringe revealed the balloon would not inflate due to the pin hole at the tip leaking. The location of the balloon puncture is consistent with in vivo contact with sharp object, such as bone splinters. 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 S. DE R.L DE C.V.
avenida paseo cucapah # 10510
parque industrial ei lago
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO S. DE R.L DE C.V.
avenida paseo cucapah # 10510
parque industrial ei lago
tijuana,bc 22570
MX 22570
Manufacturer Contact
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key8369292
MDR Text Key137132699
Report Number9612164-2019-00635
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeTW
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,Followup
Report Date 05/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberK09A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2019
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

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