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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVLOCK ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC NAVLOCK ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734678
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2022
Event Type  malfunction  
Event Description
Medtronic received information regarding a navigation system being used during a spinal procedure. During a procedure, the awl tip could not be detached from the instrument tracker. Following the procedure, the site was able to remove it. Detachment with other instrument trackers was attempted and "felt like the awl was getting stuck. " it was noted that installation was not possible. Further actions would include maintenance and replacement. The reported issue did not result in a procedure delay. There was no impact on patient outcome.
 
Manufacturer Narrative
The awl tip was returned to the manufacturer for analysis. Analysis found that the instrument had impact marks at the back end of it, causing the reported fit issues with the mating tracker. Analysis found that the reported event was related to physical damage. Codes b01, c07 and d02 are applicable to this analysis. 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 NameNAVLOCK
Type of DeviceORTHOPEDIC 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 Key14379162
MDR Text Key300043038
Report Number1723170-2022-00737
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K124004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number9734678
Device Catalogue Number9734678
Device Lot Number181020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2018
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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