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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK, INC. CD HORIZON SEXTANT II ROD INSERTION SYSTEM GUIDEWIRE, BLUNT

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MEDTRONIC SOFAMOR DANEK, INC. CD HORIZON SEXTANT II ROD INSERTION SYSTEM GUIDEWIRE, BLUNT Back to Search Results
Catalog Number 8670002
Event Date 05/24/2010
Event Type  Malfunction  
Event Description

Surgeon was using a stryker tps drill to place a medtronic guide wire when the wire fractured and a mm fragment was retained within the s1 vertebral body. Surgeon's note indicated sclerotic bone at s1. Guidewire was obtained from an instrument set supplied by medtronic representative who was present in the or. ====================== health professional's impression======================the wire fractured during placement and a mm fragment was retained. ====================== manufacturer response for guidewire, medtronic guidewire======================company representative was is room at time of occurrence.

 
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Brand NameCD HORIZON SEXTANT II ROD INSERTION SYSTEM
Type of DeviceGUIDEWIRE, BLUNT
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK, INC.
1800 pyramid place
memphis TN 38132
MDR Report Key1712272
Report Number1712272
Device Sequence Number1
Product CodeNKB
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 05/26/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/28/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue Number8670002
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/28/2010
Event Location Hospital

Patient TREATMENT DATA
Date Received: 05/28/2010 Patient Sequence Number: 1
Treatment
NO OTHER THERAPIES
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