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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2024-08-22Z-0050-2025Class IIOpen, ClassifiedDue to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.Distribution: Worldwide - U.S Nationwide distribution including in the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, TN, TX, UT, VA, WA, WI and WV. The countries of Argentina, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, Brazil, BULGARIA, CANADA, CHILE, China, Colombia, Costa Rica, CROATIA, CYPRUS, DENMARK, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, ICELAND, India, ISRAEL, ITALY, Japan, Jordan, KAZAKHSTAN, KENYA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, Malaysia, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, OMAN, PAKISTAN, PANAMA, Philippines, POLAND, PUERTO RICO, QATAR, Republic of Korea, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, Singapore, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, Turkey, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM.1,801 systemsclearance family
Regulatory clearances
  • 510(k)K201189Substantially equivalent (SESE) · 2020-05-29clearance family

Predicate lineage

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2024-02-09VAIVoluntary action indicatedMedtronic Navigation, Inc.3
2021-06-29VAIVoluntary action indicatedMedtronic Navigation, Inc.3
2019-09-30VAIVoluntary action indicatedMedtronic Navigation, Inc.1
2016-08-18VAIVoluntary action indicatedMedtronic Navigation, Inc.0
2014-12-15NAINo action indicatedMedtronic Navigation, Inc.0
2014-02-19VAIVoluntary action indicatedMedtronic Navigation, Inc.5
2012-09-06NAINo action indicatedMedtronic Navigation, Inc.0
2012-05-01NAINo action indicatedMedtronic Navigation, Inc.0
2011-03-24VAIVoluntary action indicatedMedtronic Navigation, Inc.1
2010-05-07WLWarning LetterMedtronic Navigation, Inc.—
2010-02-04OAIOfficial action indicatedMedtronic Navigation, Inc.9
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