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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK ARTHROSCOPE

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MEDTRONIC SOFAMOR DANEK ARTHROSCOPE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Inadequate Pain Relief (2388); Collapse (2416)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Literature citation: ryo kitagawa (effectiveness of balloon kyphoplasty for vertebral fracture with neurological disorder). 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.
 
Event Description
It was written in an abstract that total of 116 patients underwent balloon kyphoplasty in this hospital from 2011 jan to 2014 nov. Of those, 11 patients with neurological symptoms in lower limbs were subjected in this study. Post-operatively, in one patient the symptoms did not improve. The patient suffered l2 compression fracture. From the injury, she had low back pain and left femoral pain. For a care, she underwent balloon kyphoplasty and exhibited improvement of radiculopathy. Leg pain recurred 1 year after the surgery. Ct revealed collapse of treated vertebral body and protrusion of posterior wall in spinal canal and a posterior fusion was performed. No malfunction of the product is reported.
 
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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
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5818554
MDR Text Key100482903
Report Number1030489-2016-02171
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received06/27/2016
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

Patient Treatment Data
Date Received: 07/25/2016 Patient Sequence Number: 1
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