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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK

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MEDTRONIC SOFAMOR DANEK Back to Search Results
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/22/2016
Event Type  malfunction  
Manufacturer Narrative
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 through a medwatch form (b)(4). That on (b)(6) 2016, patient underwent microdisce ctomy surgery. Intra-op, the pituitary clamp broke. The device did not do what it was supposed to do. No patient complications have been reported as a result of this event.
 
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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 Key6295425
MDR Text Key66603972
Report Number1030489-2017-00183
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 01/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received01/10/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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