Navigation SW Cranial EM 1.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04056481132422), received between Aug 30, 2019 and Sep 10, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (18 reports).

2 other recalls cover devices cleared under the same FDA submission (K092467, K213989, K223288); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Insufficient Device Problem Information

  A cranial shunt revision procedure for CSF drainage , has been performed with the aid of the Brainlab Navigation SW Cranial EM 1.1. After three navigated catheter placement attempts, without retrieving the expected CSF, the surgeon determined that these had missed the lateral ventricle and had deviated from the intended path. The surgeon then performed a re-registration and continued the procedure successfully with navigation. According to the surgeon/treating clinician:The procedure was completed successfully as intended with navigation.There was no serious/critical harm or negative clinical effect to the patient due to the deviating catheter placement attempts. Nevertheless for successful outcome of the surgery CSF instillation was performed to restore adequate catheter flow.There was no reported serious/critical harm or negative clinical effect due to the prolonged surgery/anesthesia of Ca.2.5 hours.There were further no remedial actions necessary, done or planned for this patient. There was also no prolongation of hospitalization.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716681 ↗
• InjuryAug 26, 2026Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  A cranial surgery for a shunt placement in the brain, for drainage of Cerebrospinal fluid (CSF), has been performed with the aid of the Brainlab Navigation SW Cranial EM 1.1 After three navigated shunt placement attempts, without retrieving the expected CSF, the surgeon determined that these had missed the ventricle and had deviated from the intended path. Navigation discontinued and surgeon placed the shunt successfully freehanded.According to the surgeon (treating clinician):- The outcome of the surgery was successful as intended, without the aid of Navigation.- There was no (direct or increased) risk of harm to a critical structure due to the deviating shunt placement attempts.- There was no resulting harm or negative effect to the patient, also not due to the surgery/anesthesia prolongation of ca. 30-60min.- There were further no remedial actions necessary, done or planned for this patient. There was also no prolongation of hospitalization.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50455885 ↗
• InjuryMay 21, 2026Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR THE PLACEMENT OF A SHUNT IN A VENTRICLE, CA. 6 CM DEEP, IN THE BRAIN HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SW CRANIAL EM, VERSION 1.1. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF THE SHUNT PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON BEFORE FINALIZING THE SURGERY, AND ITS PLACEMENT WAS CORRECTED WITHOUT NAVIGATION AT THE VERY SAME SURGERY. THERE WAS NO ACTUAL NEGATIVE CLINICAL EFFECT ON THE PATIENT DUE TO THE DEVIATING SHUNT PLACEMENT DESPITE A DIRECT (OR AN INCREASED) RISK OF HEMORRHAGING TO CRITICAL STRUCTURES. THERE WAS NO NEGATIVE EFFECT ON THE PATIENT DUE TO THE PROLONGED ANESTHESIA OF CA 20 MINUTES. THERE WERE NO FURTHER REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION OF THE PATIENT WAS NOT PROLONGED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25246816 ↗
• InjuryApr 9, 2026Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR A SHUNT PLACEMENT INTO THE FOURTH VENTRICLE HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB SOFTWARE NAVIGATION SW CRANIAL EM 1.1. AFTER AN UNSUCCESSFUL ATTEMPT WAS MADE TO PLACE THE SHUNT, THE SURGEON USED ULTRASOUND TO VERIFY PATIENT ANATOMY AND DETECTED AN INACCURACY OF THE NAVIGATION DISPLAY. THE SURGERY WAS CONTINUED WITHOUT NAVIGATION. FURTHER DETAILS OF THE EFFECTS ON THE PATIENT COULD NOT YET BE RETRIEVED FROM THE HOSPITAL. BRAINLAB CONTINUES TO FOLLOW-UP WITH THE USER FACILITY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24826186 ↗
• InjurySep 5, 2025Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A SHUNT PLACEMENT INTO THE THIRD VENTRICLE IN THE BRAIN WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL EM 1.1. THE SURGEON DISCOVERED ON A POST-OPERATIVE CT SCAN THAT THE SHUNT DEVIATED AND WAS PLACED INCORRECTLY, A REVISION SURGERY WAS SCHEDULED TO CORRECT THE SHUNT PLACEMENT TO THE INTENDED POSITION. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF THE SHUNT CATHETER PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON WITH A POST-OP CT, A REVISION SURGERY WAS SCHEDULED FOR AND TOOK PLACE ONE DAY AFTER THE INITIAL SURGERY. THE FINAL OUTCOME OF THE REVISION SURGERY WAS SUCCESSFUL AS INTENDED, WITH CORRECT SHUNT PLACEMENT AT THE END OF THE SURGERY. -THERE WAS NO HARM NOR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING SHUNT PLACEMENT, DESPITE A DIRECT/INCREASED RISK OF HARM TO A CRITICAL STRUCTURE, THERE WAS NO PROLONGATION OF THE ORIGINAL SURGERY / ANESTHESIA REPORTED (DEVIATION WAS DETECTED ONLY AFTERWARDS), ALSO NO HARM NOR NEGATIVE EFFECT DUE TO SURGERY/ANESTHESIA REPEAT OF 45-60 MIN FOR THE REVISION SURGERY THE FOLLOWING DAY. THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, NEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976342 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR A VENTRICULOPERITONEAL (VP) SHUNT PLACEMENT INTO THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SW CRANIAL EM VERSION 1.1. FROM A POST-OPERATIVE SCAN, THE SURGEON DISCOVERED THAT THE PLACEMENT OF THE VP SHUNT DEVIATED FROM ITS INTENDED POSITION BY ~ 2 CM. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED. THERE WAS NO DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE DUE TO THE DEVIATING SHUNT PLACEMENT. THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING PLACEMENT. THERE WERE FURTHER NO REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS NOT PROLONGED EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22560141 ↗
• InjuryOct 30, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  A CRANIAL SURGERY FOR A VENTRICULAR SHUNT PLACEMENT INTO THE RIGHT VENTRICLE, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAIN LAB NAVIGATION SOFTWARE NAVIGATION SW ENT EM 1.1. DETAILED DESCRIPTION: A PRE-OPERATIVE CT SCAN WAS ACQUIRED THE DAY OF THE SURGERY TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT LATERALLY AND ATTACHED THE NON-INVASIVE EM PATIENT REFERENCE FOR NAVIGATION TO THE PATIENT'S HEAD. PERFORMED THE PATIENT REGISTRATION WITH SURFACE MATCHING BY ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN SURFACE WITH THE EM REGISTRATION POINTER TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY, VERIFIED THE ACCURACY OF THE PATIENT REGISTRATION AND ACCEPTED THE REGISTRATION TO PROCEED. PLANNED THE ENTRY POINT OF THE SKIN INCISION. CREATED A BURR HOLE AT THE ENTRY POINT AND OPENED THE DURA, WITHOUT THE AID OF NAVIGATION. SUCCESSFULLY UPDATED THE ENTRY POINT WITH THE NAVIGATED EM DISPOSABLE STYLET. VERIFIED THE UPDATED TRAJECTORY USING THE STYLET AND DEEMED IT ACCEPTABLE TO PROCEED. PUT THE STYLET INSIDE A NON-BRAIN LAB SHUNT CATHETER AND ATTEMPTED TO PLACE THE SHUNT INTO THE VENTRICLE, TO THE TARGET AS DISPLAYED BY NA

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 20566654 ↗
• InjuryOct 2, 2024Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A VENTRICULAR SHUNT PLACEMENT INTO THE RIGHT VENTRICLE, CA. 8 CM DEEP IN THE BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SW CRANIAL EM, VERSION 1.1. FROM A POST-OP CT SCAN THE SURGEON DISCOVERED THAT THE SHUNT WAS PLACED CA. 10 MM POSTERIOR TO ITS INTENDED POSITION. DETAILED DESCRIPTION: TWO DAYS BEFORE THE SURGERY A T1 MRI SCAN WAS ACQUIRED TO USE WITH NAVIGATION. DURING THE PROCEDURE, THE SURGEONS: - POSITIONED THE PATIENT IN A SUPINE ORIENTATION WITH THE HEAD SLIGHTLY ROTATED AND FIXATED IN A NON-BRAINLAB HORSESHOE HEAD HOLDER. - ATTACHED THE NON-INVASIVE EM NAVIGATION REFERENCE TO THE PATIENT'S HEAD APPROXIMATELY 1 INCH ABOVE THE RIGHT EYE WITH TAPE. - PERFORMED THE IMAGE REGISTRATION OF THE T1 MRI SCAN TO NAVIGATION, VIA SURFACE MATCHING BY ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN SURFACE WITH THE EM REGISTRATION POINTER, TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. - VERIFIED THE ACCURACY OF THE PATIENT REGISTRATION TO NAVIGATION AND WERE UNSATISFIED WITH THE RESULT. - COLLECTED ADDITIONAL POINTS ON THE PATIENT'S SKIN WITH THE POINTER. - VERIFIED THE ACCURACY OF THE PATIENT REGISTRATION TO NAVIGA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350816 ↗
• InjurySep 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A CRANIAL SURGERY, FOR THE PLACEMENT OF A SHUNT IN A PATIENT'S BRAIN, WAS PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE CRANIAL EM, VERSION 1.1. FROM A POST-OPERATIVE SCAN, THE SURGEON DETERMINED THAT THE SHUNT WAS PLACED IN A DIFFERENT POSITION IN THE PATIENT'S BRAIN THAN INTENDED. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF THE SHUNT PLACED WITH THE AID OF NAVIGATION WAS DETECTED WITH A POST-OPERATIVE SCAN. CLINICALLY, THE PATIENT WAS IN GOOD CONDITION AND UNDER OBSERVATION. DESPITE CONTINUED FOLLOW UP BY BRAINLAB, THE HOSPITAL HAS NOT PROVIDED ANY FURTHER INFORMATION ON THE PATIENT'S CLINICAL OUTCOMES. THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT REPORTED. THERE WAS NO REPORTED CHANGE OF THE SURGICAL PROCEDURE FROM ITS ORIGINAL PLAN. THERE WAS NO PROLONGATION OF THE SURGERY / ANESTHESIA REPORTED. NO REMEDIAL ACTIONS FOR THE PATIENT WERE REPORTED THAT WOULD HAVE BEEN DONE, NECESSARY OR PLANNED, AND NO PROLONGATION OF HOSPITALIZATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300117 ↗
• InjuryJun 7, 2024Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A VENTRICULOPERITONEAL (VP) SHUNT PLACEMENT INTO THE LATERAL HORN OF THE RIGHT VENTRICLE, CA. 9CM DEEP IN THE BRAIN, TO DRAIN CEREBROSPINAL FLUID (CSF) DUE TO A HYDROCEPHALUS, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SW CRANIAL EM VERSION 1.1. A PRE-OPERATIVE CT SCAN WAS ACQUIRED BEFORE THE SURGERY THE SAME DAY, TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEONS: - POSITIONED THE PATIENT IN A SUPINE ORIENTATION WITH HEAD TURNED LEFT FIXATED IN A NON-BRAINLAB HORSE SHOE HEAD HOLDER, AND ATTACHED THE NON-INVASIVE EM NAVIGATION REFERENCE TO THE PATIENT'S HEAD. - PERFORMED THE IMAGE REGISTRATION OF THE CT SCAN TO NAVIGATION, WITH LANDMARK MATCHING BY ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN SURFACE WITH THE EM REGISTRATION POINTER, TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. - VERIFIED THE ACCURACY OF THE PATIENT REGISTRATION TO NAVIGATION, DETERMINED THE RESULT AS LESS THAN OPTIMAL BUT SUFFICIENT FOR THE INTENDED PLACEMENT, AND ACCEPTED THE REGISTRATION TO PROCEED. - EXPOSED THE SKULL AT THE INTENDED PLACEMENT LOCATION AND DETERMINED THE ENTRY POINT FOR THE BURR HOLE WITH THE NAVIGATED EM DISPOSABLE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19490002 ↗
• InjuryNov 14, 2023Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A SHUNT PLACEMENT INTO THE VENTRICLE RIGHT SIDE, CA. 6CM DEEP IN THE BRAIN, TO DRAIN CEREBROSPINAL FLUID (CSF), HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SW CRANIAL EM VERSION 1.1. A PRE-OPERATIVE CT SCAN WAS ACQUIRED CA. 2 WEEKS BEFORE THE SURGERY TO USE WITH NAVIGATION. A TRAJECTORY FOR THE SHUNT PLACEMENT WAS PLANNED IN THE NAVIGATION SYSTEM ON THE DAY OF THE SURGERY BEFOREHAND. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A SUPINE ORIENTATION WITH HEAD TURNED LEFT FIXATED IN A NON-BRAINLAB HEAD HOLDER, AND ATTACHED THE NON-INVASIVE EM NAVIGATION REFERENCE TO THE PATIENT'S HEAD. - PERFORMED THE IMAGE REGISTRATION WITH SURFACE MATCHING BY ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN SURFACE WITH THE EM POINTER TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. - VERIFIED THE ACCURACY OF THE PATIENT REGISTRATION TO NAVIGATION, DETERMINED THE RESULT AS GOOD, AND ACCEPTED THE REGISTRATION TO PROCEED. - DETERMINED THE PLANNED TRAJECTORY'S ENTRY POINT WITH THE NAVIGATED EM DISPOSABLE STYLET ON THE PATIENT'S HEAD, AND MARKED THIS POINT WITH A PEN ON THE SKIN FOR THE INCISION. - DRAPED THE PATIENT, AND RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18128727 ↗
• InjurySep 21, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  AN ENDOSCOPIC SINUS SURGERY (ETHMOIDECTOMY), WITH A TARGET REGION AT A DEPTH OF 1-2 MM AND A SIZE OF 4 MM, TO TREAT CHRONIC SINUSITIS AND POLYPOID MASS LESIONS, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAV. SW CRANIAL EM 1.1 (ON (B)(6) 2023). THREE PRE-OPERATIVE CT SCANS WERE ACQUIRED 78 DAYS PRIOR TO THE SURGERY (ON (B)(6) 2023), TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT SUPINE, WITH A ROUND SUPPORT PILLOW (DONUT) UNDER THE HEAD, AND ATTACHED THE NON-INVASIVE EM PATIENT REFERENCE FOR NAVIGATION TO THE PATIENT'S FOREHEAD WITH TAPE. PERFORMED THE PATIENT REGISTRATION WITH SURFACE MATCHING BY ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN SURFACE WITH THE EM REGISTRATION POINTER TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY, VERIFIED THE ACCURACY OF THE PATIENT REGISTRATION AND ACCEPTED THE REGISTRATION TO PROCEED CALIBRATED THE BRAINLAB SUCTION TUBE WITH STRAIGHT TIP END AND THE BRAINLAB SUCTION TUBE WITH CURVED TIP END USING THE STERILE EM POINTER. PERFORMED A SEPTOPLASTY (SURGICAL PROCEDURE TO STRAIGHTEN A DEVIATED SEPTUM) WITHOUT AID OF NAVIGATION. PERFORMED BILATERAL SINUS SURGERY USING AID OF NAVIGATION,

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 17787149 ↗
• InjuryMay 17, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A CRANIAL SURGERY (ON (B)(6) 2023) FOR PLACEMENT OF A VENTRICULOATRIAL (VA) SHUNT IN THE BRAIN'S RIGHT VENTRICLE, DUE TO HYDROCEPHALUS, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SW CRANIAL EM 1.1.5. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT SUPINE (WITH HEAD TURNED TO THE LEFT FOR RIGHT SIDE ACCESS) AND ATTACHED THE NON-INVASIVE EM PATIENT REFERENCE FOR NAVIGATION TO THE PATIENT WITH TAPE. PLANNED THE TRAJECTORY (RIGHT OCCIPITAL TO LEFT FRONTAL HORN) . PERFORMED THE PATIENT REGISTRATION ON THE PREOPERATIVE MRI ACQUIRING REGISTRATION POINTS ON THE PATIENT HEAD'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT. PATIENT ANATOMY: VERIFIED THE ACCURACY OF THE PATIENT REGISTRATION AND JUDGED IT TO BE GOOD. PLANNED THE INCISION, ADJUSTED THE PLANNED TRAJECTORY'S ENTRY POINT, DRAPED THE PATIENT, VERIFIED ACCURACY OF REGISTRATION AGAIN AND JUDGED IT TO BE GOOD. MADE THE INCISION AND BURR HOLE AND THE POCKET FOR THE SHUNT VALVE (NO NAVIGATION USED TO PLAN/DO THE POCKET). OPENED THE DURA, VERIFIED ACCURACY OF REGISTRATION AND JUDGED IT TO BE GOOD. PLACED THE CATHETER WITH AID OF NAVIGATION (PUT NAVIGATED BRAINLAB EM STYLET INSIDE NON-BRAINL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16944365 ↗
• InjuryMar 9, 2023Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A VENTRICULOPERITONEAL (VP) SHUNT PLACEMENT TO TREAT IDIOPATHIC INTRACRANIAL HYPERTENSION (IIH) IN THE BRAIN'S RIGHT VENTRICLE, AT A DEPTH OF 62.6MM, WITHIN A SMALL SIZED VENTRICLE (SLIT VENTRICLE), HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAV. SW CRANIAL EM 1.1 (ON (B)(6) 2023). A PRE-OPERATIVE CT SCAN WAS ACQUIRED ONE DAY PRIOR TO THE SURGERY, TO PREPLAN THE TRAJECTORY, AND TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEONS: - POSITIONED THE PATIENT SUPINE AND ATTACHED THE NON-INVASIVE EM PATIENT REFERENCE FOR NAVIGATION TO THE PATIENT'S FOREHEAD WITH TAPE. - PERFORMED THE PATIENT REGISTRATION WITH SURFACE MATCHING BY ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN SURFACE WITH THE EM REGISTRATION POINTER TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY, VERIFIED THE ACCURACY OF THE PATIENT REGISTRATION AND ACCEPTED THE REGISTRATION TO PROCEED. - MARKED THE PLANNED ENTRY POINT/BURR HOLE ON THE PATIENT'S SKIN USING ANATOMICAL LANDMARKS, AND ADJUSTED THE PLANNED TRAJECTORY'S ENTRY POINT TO MATCH THE BURR HOLE. - DRAPED THE PATIENT, VERIFIED THE ACCURACY OF THE PATIENT REGISTRATION AGAIN AND DETERMINED IT GOOD. - MADE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16511634 ↗
• InjurySep 23, 2021Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A RIGHT VENTRICLE DRAIN PLACEMENT, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL EM 1.1. A PRE-OPERATIVE MRI WAS ACQUIRED ONE DAY PRIOR TO THE SURGERY FOR USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEONS: POSITIONED THE PATIENT SUPINE AND ATTACHED THE NON-INVASIVE EM PATIENT REFERENCE TO THE PATIENT'S FOREHEAD WITH TAPE. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP MRI ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE REGISTRATION AND DEEMED IT NOT YET ACCEPTABLE, AND PERFORMED THE REGISTRATION AGAIN MULTIPLE TIMES, UNTIL AN ACCEPTABLE REGISTRATION WAS ACHIEVED (ALTHOUGH THE SURGEON ACKNOWLEDGED IT WAS LESS THAN IDEAL). THE SURGEON ACCEPTED THIS FINAL REGISTRATION RESULT TO PROCEED. USED THE NAVIGATED POINTER TO MARK THE ENTRY POINT ON THE PATIENT'S SKIN AND DRAPED THE PATIENT. PERFORMED THE NON-NAVIGATED TUNNELING PORTION OF THE PROCEDURE, USING A ROD TO BRING THE DRAIN BELOW THE SKIN AND DIRECTING IT TOWARDS THE ABDOMEN, FOR DRAINING OF THE CEREBROSPINAL FLUID (CSF). MADE A SKIN INCISION AND CREATED T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12521149 ↗
• InjuryJun 16, 2021Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A VENTRICULOPERITONEAL (VP) SHUNT PLACEMENT TO DRAIN CEREBROSPINAL FLUID (CSF) FROM THE BRAIN'S RIGHT VENTRICLE, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL EM NAVIGATION VERSION 1.1.2 (ON (B)(6) 2021). A PRE-OPERATIVE CT SCAN WAS ACQUIRED THE DAY OF THE SURGERY, TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A SUPINE ORIENTATION WITH HEAD TURNED LEFT ON A HORSESHOE HEADREST ON THE OR TABLE. FIXATED THE NON-INVASIVE EM REFERENCE ON THE PATIENT'S FOREHEAD (AND FIXED THE CABLE ON THE PATIENT TO PREVENT STRAIN/TENSION/PULLING OF THE CABLE). PERFORMED THE IMAGE REGISTRATION WITH SURFACE MATCHING BY ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN SURFACE WITH THE EM REGISTRATION POINTER TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE PATIENT REGISTRATION TO NAVIGATION, DETERMINED THE RESULT AS LESS THAN OPTIMAL, BUT GOOD ENOUGH FOR THIS PROCEDURE, AND ACCEPTED THE REGISTRATION TO PROCEED (TO USE AID OF NAVIGATION "TO SOME EXTENT" IN COMBINATION WITH RELYING ON THE SURGEON'S OWN ESTIMATE BASED ON PATIENT ANATOMY). DRAPED THE PATIENT, AND HAD ADDITIONAL STRAIN REL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12006997 ↗
• InjuryJun 11, 2021Use of Device Problem; Use of Device Problem

  A CRANIAL SURGERY FOR A VENTRICULOPERITONEAL (VP) SHUNT PLACEMENT TO DRAIN CEREBROSPINAL FLUID (CSF) FROM THE BRAIN'S RIGHT VENTRICLE, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL EM NAVIGATION VERSION 1.1. A PRE-OPERATIVE CT SCAN WAS ACQUIRED THE DAY OF THE SURGERY, TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A SUPINE ORIENTATION WITH HEAD TURNED LEFT ON A HORSESHOE HEADREST ON THE OR TABLE. FIXATED THE NON-INVASIVE EM REFERENCE ON THE PATIENT'S FOREHEAD. PERFORMED THE IMAGE REGISTRATION WITH SURFACE MATCHING BY ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN SURFACE WITH THE EM REGISTRATION POINTER TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE PATIENT REGISTRATION TO NAVIGATION, DETERMINED THE RESULT AS GOOD, AND ACCEPTED THE REGISTRATION TO PROCEED. DRAPED THE PATIENT. DETERMINED THE ENTRY POINT WITH THE NAVIGATED EM DISPOSABLE STYLET, AND CREATED THE BURR HOLE. PUT THE NAVIGATED EM STYLET INSIDE THE NON-BRAINLAB SHUNT CATHETER, AND PLACED THE SHUNT INTO THE VENTRICLE, TO THE TARGET AS DISPLAYED BY THE NAVIGATION. DID NOT SEE ANY CSF FLOW FROM THE CATHETER WHEN REMOVING T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11981605 ↗
• InjuryMar 25, 2021Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A CRANIAL SURGERY FOR A VENTRICULOPERITONEAL (VP) SHUNT PLACEMENT TO DRAIN CEREBROSPINAL FLUID (CSF) FROM THE SUPERIOR PORTION OF THE RIGHT VENTRICLE (APPROX. 46.4 MM IN DEPTH), HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE CRANIAL EM 1.1 (ON (B)(6) 2021). A PRE-OPERATIVE CT SCAN WAS ACQUIRED THE SAME DAY, TO USE WITH NAVIGATION. A TRAJECTORY WAS CREATED PREOPERATIVELY TARGETING THE RIGHT VENTRICLE (ENTRY POINT WAS INTENDED TO BE NAVIGATED/ADAPTED INTRAOPERATIVELY). DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN SUPINE POSITION WITH HEAD TURNED TO THE LEFT ON A NON-BRAINLAB HORSESHOE HEAD HOLDER. SECURED THE PATIENT REFERENCE (NON-INVASIVE) TO THE PATIENT'S FOREHEAD WITH TAPE. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PREOPERATIVE CT SCAN USING THE EM. REGISTRATION POINTER ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY, VERIFIED THE ACCURACY OF THE REGISTRATION AND DETERMINED IT NOT SUFFICIENTLY ACCURATE PERFORMED A NEW PATIENT REGISTRATION, BUT WITH THE PATIENT HEAD POSITIONED SUPINE, VERIFIED THE ACCURACY OF THE REGISTRATION AND DETERMINED IT (NOT IDEAL BUT) SUFFI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567047 ↗
• InjuryDec 16, 2020Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  A CRANIAL SURGERY FOR PLACEMENT OF THREE LEADS FOR A RESPONSIVE NEUROSTIMULATION (RNS) SYSTEM, WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL EM 1.1. A PREOPERATIVE MRI SCAN WAS ACQUIRED APPROXIMATELY FOUR MONTHS PRIOR TO THE SURGERY, TO USE WITH THE ELECTROMAGNETIC (EM) NAVIGATION. THREE TRAJECTORIES WERE PLANNED ON THE MRI SCAN PRE-OPERATIVELY IN THE NAVIGATION SOFTWARE. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN SUPINE POSITION WITH LATERAL HEAD TILT TO THE RIGHT, PLACING THE PATIENT'S HEAD ON A HORSESHOE HEAD HOLDER. SECURED THE PATIENT REFERENCE TO THE PATIENT'S HEAD WITH TAPE. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PREOPERATIVE MRI USING THE EM REGISTRATION POINTER ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE REGISTRATION AND ACCEPTED THE REGISTRATION TO PROCEED. DRAPED THE PATIENT, EXPOSED THE SKULL, AND VERIFIED ACCURACY OF THE NAVIGATION. DETERMINED THE THREE BURR HOLE PLACEMENTS USING THE AID OF NAVIGATION BASED ON THE ENTRY POINTS OF THE PRE-PLANNED TRAJECTORIES, AND CREATED THE BURR HOLES USING A NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11020638 ↗
• InjuryOct 21, 2019Use of Device Problem; Use of Device Problem

  AN EMERGENCY CRANIAL SURGERY TO IMPLANT AN EXTERNAL VENTRICULAR DRAIN (EVD) SHUNT FOR CSF DRAINAGE, DUE TO THE PATIENT'S HIGH INTRACRANIAL PRESSURE (ICP), INTENDED FROM LEFT INTO THE INTERVENTRICULAR FORAMINA, LOCATED CA. 65MM DEEP IN THE BRAIN WITH A SIZE OF CA. 2MM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL EM NAVIGATION 1.1. A PRE-SURGERY CT SCAN WAS ACQUIRED 2-3 HOURS BEFORE THE SURGERY, TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN A SUPINE ORIENTATION ON THE OR TABLE, AND ATTACHED THE TAPED (NON-INVASIVE) EM PATIENT REFERENCE TO THE RIGHT SIDE OF THE PATIENT'S FOREHEAD. PERFORMED THE IMAGE REGISTRATION WITH SURFACE MATCHING WITH ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN SURFACE (FOREHEAD ONLY) TO MATCH THE DISPLAY OF THE EM NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE PATIENT REGISTRATION TO NAVIGATION, AND ACCEPTED THE REGISTRATION TO PROCEED. PLANNED THE TRAJECTORY TO TARGET WITH THE EM POINTER, AND MARKED THE ENTRY POINT ON THE PATIENT'S SKIN. DRAPED THE PATIENT, PERFORMED THE SKIN INCISION, RE-CHECKED THE ENTRY POINT WITH NAVIGATION, AND DRILLED THE BURR HOLE. PLACED THE EVD SHUNT GUI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9213901 ↗
• InjuryAug 30, 2019Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  WHAT IS THE ISSUE? A CRANIAL SURGERY FOR PLACEMENT OF A VENTRICULOPERITONEAL (VP) SHUNT CATHETER FOR CSF DRAINAGE WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL EM 1.1. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN SUPINE POSITION ON THE OR TABLE. PERFORMED AN INTRAOPERATIVE CT SCAN AND PLANNED A TRAJECTORY. ATTACHED THE NON-INVASIVE EM REFERENCE TO THE PATIENT'S FOREHEAD. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE INTRAOPERATIVE CT SCAN USING THE EM REGISTRATION POINTER ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY VERIFIED THE ACCURACY OF THE REGISTRATION AT SEVERAL ANATOMICAL LANDMARKS, JUDGED IT AS VERY GOOD, AND ACCEPTED THE REGISTRATION TO PROCEED. DRAPED THE PATIENT AND PERFORMED THE CRANIOTOMY. INSERTED THE CATHETER WITH THE AID OF A NAVIGATED EM STYLET ALIGNING TO THE PLANNED TRAJECTORY. REMOVED THE EM STYLET AND OBSERVED AN INITIAL FLOW OF CSF OUT OF THE CATHETER, WHICH QUICKLY SLOWED AND CEASED. REPEATED THE TWO ABOVE STEPS SEVERAL TIMES WITH THE SAME RESULT. PERFORMED AN INTRAOPERATIVE CT SCAN AND DETERMINED THE CATHETER TIP WAS LOCATED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8950713 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092467, K213989, K223288. One submission often covers many models, so check the product and lot details in each record.

• Z-0056-2021 · Aug 31, 2020 · Terminated
  Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided l
• Z-0598-2016 · Apr 22, 2013 · Terminated
  Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative imag