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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number UNK_NAV_COMP
Device Problems Material Fragmentation (1261); Appropriate Term/Code Not Available (3191)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/17/2023
Event Type  Injury  
Manufacturer Narrative
H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.Codes b17, c20, d15 are applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used during a sacroiliac and thoracolumbar procedure.It was reported that during the procedure, the thoracic awl tip broke off in the patient's pedicle.The site was unable to remove the fragment and left the metal fragment in the patient.
 
Event Description
Additional information was received.The manufacturer representative (rep) confirmed that the site was using another manufacturer's awl with our system.The awl was what got damaged and there was no complaint against the navigation system.
 
Manufacturer Narrative
Additional information added.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
MEDTRONIC NAVIGATION
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key18325972
MDR Text Key330493872
Report Number1723170-2023-02762
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUNK_NAV_COMP
Device Catalogue NumberUNK_NAV_COMP
Device Lot Number170606
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/05/2024
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 Unknown
Patient Sequence Number1
Treatment
SEE H10.
Patient Outcome(s) Required Intervention; Required Intervention;
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