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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
Model Number KPT1002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Exsanguination (1841)
Event Date 03/05/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the healthcare professional (hcp) via the manufacturer representative regarding an event which occurred during a kyphoplasty procedure in a patient diagnosed with primary osteoporosis, compression fracture and intravertebral cleft. It was reported that there was pulsatile bleeding when the bone access needle was inserted, and the inner cylinder was removed. The physician waited for the bleeding to stop with the inner cylinder inserted for about 5 minutes, but the degree of bleeding did not change. The guide pin and osteo introducer were inserted immediately, and cement was filled with bfd. Balloon was not used with the highest priority being to obtain hemostasis. During cement filling, there was a lot of bleeding and cement leaked into the spinal canal from the damaged posterior wall. In the preoperative evaluation, there was pulsatile bleeding due to the insertion of a bone access needle without noticing that there was an aneurysm in the vertebral body. It was not a product defect. There was a delay of less the 60 mins in the overall procedure. The cement was mixed and stored as per ifu. Patient is in hospital and is making satisfactory progress. No neurological symptoms. No patient injury / complication post-surgery. Bone access needle included in the kit kpt1002. Cement used for the surgery remains in patient. Products will not be returned since they were discarded or remained in patient. There was patient injury /complication.
 
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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
tricha miles
1800 pyramid place
memphis, TN 38132
7635140379
MDR Report Key11573609
MDR Text Key242370636
Report Number9612164-2021-01164
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 Other Health Care Professional
Type of Report Initial
Report Date 03/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKPT1002
Device Catalogue NumberKPT1002
Device Lot Number221527206
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 Received03/05/2021
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

Patient Treatment Data
Date Received: 03/26/2021 Patient Sequence Number: 1
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