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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 Problem Collapse (2416)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Literature citation: y. Oishi, m. Murase, j. Tanimoto, y mano, d. Tateiwa and j. Hamawaki" global malalignment deteriorates clinical results of bkp to the patients with delayed union of osteoporotic vertebral fracture". 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 reported in an abstract that total of 51 patients with delayed union or pseudarthrosis developed after osteoporotic vertebral fracture(male:7, female:44, mean age:79) who were followed up for a year at minimum underwent bkp in the periods between 2011 - 2014 in this hospital. Post-op, vertebral collapses at balloon kyphoplasty-treated levels were observed for 98%.
 
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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 Key5656260
MDR Text Key100313447
Report Number1030489-2016-01412
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 04/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2016
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 Received04/14/2016
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: 05/16/2016 Patient Sequence Number: 1
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