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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 Unspecified Infection (1930); Pain (1994)
Event Date 06/30/2014
Event Type  Injury  
Event Description
It was reported that a patient underwent balloon kyphoplasty (bkp) at t12 to treat a vertebral compression fracture.Approximately two months post-op, it was noted that the patient had a high level of crp (c-reactive protein) and mri imaging tests showed potential infection.According to the report "it was doubted that the infection was caused from antibiotic medication as it relieved the patient's pain but is now stable".No other information was reported.
 
Manufacturer Narrative
(b)(4).Location : unknown although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
 
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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
huzefa mamoola
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key3972140
MDR Text Key19586341
Report Number2953769-2014-00100
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,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 07/02/2014
Initial Date FDA Received07/31/2014
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;
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