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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC THORACIC CLAMP; INSTRUMENT, STEREOTAXIC
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MEDTRONIC NAVIGATION, INC THORACIC CLAMP; INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733148
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 06/05/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The thoracic clamp was returned to the manufacturer for analysis.Analysis found that the adjustment screw threads are damaged.Analysis found that the reported event was related to a physical damage issue.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information regarding a navigation device.It was reported the thoracic radiolucent spine clamp had problems in opening and closing.This issue was noted outside of a procedure, and there was no patient involvement.
 
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Brand Name
THORACIC CLAMP
Common Device Name
INSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
MDR Report Key8746147
Report Number1723170-2019-03870
Device Sequence Number13785575
Product Code HAW
UDI-Device Identifier00613994201263
UDI-Public00613994201263
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K990214
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number9733148
Device Catalogue Number9733148
Device Lot Number140529
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/05/2019
Initial Report FDA Received Date06/28/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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