SuperLock SDGN447Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521539709), received between Mar 9, 2017 and Dec 29, 2020 — classified as 5 injuries.

The most frequently reported specific device problem is “Application Program Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE PHYSICIAN DEPLOYED TWO MARKERS, AND THE PATIENT SEEMED FINE AND FLURO LOOKED FINE. THE PHYSICIAN WAS ABLE TO COMPLETE THE ENB PORTION OF THE CASE, HOWEVER SIX HOURS LATER THE PATIENT PRESENTED IN THE EMERGENCY ROOM (ER) WITH CHEST PAIN, AND X-RAY SHOWED THE MARKER IN THE PLEURA CAUSED PNEUMOTHORAX. TO RESOLVE THE SURGEON HAD TO PUT CHEST TUBE AND DUE TO THE ISSUE, THE PATIENT EXTENDED PATIENT HOSPITALIZATION FOR A NIGHT.

  Patient problems: Chest Pain; Pneumothorax; Unintended Radiation Exposure

  MAUDE report 11087113 ↗
• InjuryMay 13, 2020Migration or Expulsion of Device; Application Program Problem; Migration or Expulsion of Device; Application Program Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE PHYSICIAN HAD ISSUES DEPLOYING THE FIDUCIALS, EACH ONE MIGRATED UPON DEPLOYING OUT OF THE END OF THE MARKER DELIVERY KITS. WHEN TECH WAS LOADING THE FIDUCIAL INTO THE FIRST MARKER DELIVERY KIT IT BECAME LODGED IN THE PROXIMAL HUB AND COULD NOT ADVANCE THE GUIDE WIRE. THE SUPERD PORTION WAS NOT COMPLETED. IT WAS NOT COMPLETED BY OTHER MEANS. THE PATIENT WAS UNDER GENERAL ANESTHESIA.

  Patient problems: No Code Available

  MAUDE report 10054108 ↗
• InjuryAug 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED TO PATIENTS WHO RECEIVED ROBOTIC SABR FOR LUNG TUMORS FROM MAY 2015 UNTIL JANUARY 2017, ALL PATIENTS USED SUPERDIMENSION. A TOTAL OF 128 PATIENTS WITH 147 TREATED LUNG LESIONS WERE IDENTIFIED. ENB USING THE SUPERDIMENSION WAS USED TO GUIDE FIDUCIAL MARKER PLACEMENT WITH AND WITHOUT THE SUPERDIMENSION FIDUCIAL WIZARD TOOL. PATIENTS IN WHOM THE SUPERDIMENSION FIDUCIAL WIZARD TOOL ARE CALLED THE ¿FPGS GROUP¿ AND PATIENTS IN WHOM SUPERDIMENSION WAS USED WITHOUT THE FIDUCIAL WIZARD TOOL ARE CALLED ¿NON-FPGS GROUP¿. COMPLICATIONS FOR FIDUCIALS PLACED IN LESIONS THAT USED THE FPGS (N = 44) INCLUDED PNEUMOTHORAX (2.27%) AND BLEEDING (2.27%), CTCAE GRADE I AND II, RESPECTIVELY. FOR THE LESIONS THAT DID NOT UTILIZE THE FPGS (N = 103), COMPLICATIONS INCLUDED ONE INCIDENCE OF GRADE II PNEUMOTHORAX (0.97%). THE NON-FPGS COHORT DID ALSO HAVE TWO INCIDENCES OF HYPOXIA AND ONE OF HYPOTENSION. IT WILL BE NOTED THAT THE TWO THAT DEVELOPED A PNEUMOTHORAX WERE UNDERGOING CONCURRENT BIOPSY AND FIDUCIAL PLACEMENT.

  Patient problems: Blood Loss; Hypoxia; Low Blood Pressure/ Hypotension; Pneumothorax

  MAUDE report 8931895 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF STUDY, THE SAFETY AND EFFECTIVENESS OF ENB WHEN USED IN FIDUCIAL MARKER PLACEMENT. SIXTY-FOUR PATIENTS IN THIS STUDY HAD A TOTAL OF 68 LUNG LESIONS. 190 FIDUCIAL MARKERS IN THESE LESIONS. ALL FIDUCIALS PLACED WERE DIVIDED INTO TWO GROUPS, THOSE PLACED IN THE UPPER LOBES AND THOSE PLACED IN THEIR MIDDLE AND LOWER LOBES. THERE WERE THREE (5%) UNPLANNED HOSPITAL ADMISSIONS; TWO PATIENTS WITH UPPER LOBE MARKERS AND ONE PATIENT WITH A LOWER LOBE MARKER. ONE PATIENT FROM EACH GROUP (3%) SUFFERED FROM RESPIRATORY FAILURE AND TWO PATIENTS (3%) WITH MARKERS PLACED IN THE UPPER LOBES DEVELOPED A PNEUMOTHORAX.

  Patient problems: No Code Available; Pneumothorax; Respiratory Failure

  MAUDE report 8499949 ↗
• InjuryMar 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A POST-PROCEDURE RIGHT-SIDED PNEUMOTHORAX AFTER A SUPERDIMENSION ENB PROCEDURE. THE PHYSICIAN ATTRIBUTED THE EVENT TO THE PLACEMENT OF A SUPERLOCK COBRA FIDUCIAL MARKER. THE PATIENT WAS ADMITTED FOR 1 NIGHT FOR OBSERVATION.

  Patient problems: Pneumothorax

  MAUDE report 6391426 ↗