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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 No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Literature citation: yamada k, et al."short-term outcome of balloon kyphoplasty for osteoporotic vertebral fracture" mean age (b)(6) years.Fifty-two men and 162 women.(b)(4).
 
Event Description
It was reported in an abstract that between (b)(6) 2011 to (b)(6) 2014, 214 patients who underwent balloon kyphoplasty (bkp) were followed up for a minimum duration of 3 months.12 patients underwent bkp again (in a mean postoperative duration of 2.1 months).
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Type of Device
ARTHROSCOPE
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 Key6130986
MDR Text Key60988963
Report Number1030489-2016-03292
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 Physician
Type of Report Initial,Followup
Report Date 11/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2016
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 Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age77 YR
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