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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) INST KIT SPINE CLAMP; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) INST KIT SPINE CLAMP; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9735129
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/06/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have been received by the manufacturer for evaluation.Part not returned for analysis.
 
Event or Problem Description
A site representative reported that, while outside of a procedure, the spine clamp was damaged.The damage was reported to be due to a damaged screw on the clamp.The reported issue was discovered in sterilization.No additional information was provided.There was no patient present when this issue was identified.
 
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Brand Name
INST KIT SPINE CLAMP
Common Device Name
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
MDR Report Key6540275
Report Number1723170-2017-01909
Device Sequence Number1134431
Product Code HAW
UDI-Device Identifier00643169308879
UDI-Public00643169308879
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K001153
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,o
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 05/03/2017
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 Physician
Device Catalogue Number9735129
Device Lot Number160406
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/06/2017
Initial Report FDA Received Date05/03/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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