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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC TRACKER ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9733816
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2021
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. No parts have been received by the manufacturer for evaluation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regard a navigation system being used in a posterior lumbar fusion procedure. It was reported that the tracker's spring appeared to be not holding tight and had become loose. There was no reported delay to the case. No impact on patient outcome. Additional information was received stating that the same tracker was used for the remainder of the case. The spring appeared to be not holding tight and had become somewhat loose but was okay to proceed with the case using the same tracker.
 
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Brand NameTRACKER
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 Key13204877
MDR Text Key290442507
Report Number1723170-2022-00027
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeCA
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 01/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733816
Device Catalogue Number9733816
Device Lot Number181001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2018
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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