Nexframe® DB-2040 (UDI 00643169214811)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169214811), received between Oct 5, 2017 and Sep 26, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K012366); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 9, 2019Terminated

   Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging system (also known as a fiducial-less procedure). Minor patient movement may not be initially detected by the user or the software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging).

   Z-1995-2020 · Root cause: Software design · FDA record ↗

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.

• MalfunctionSep 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR MOVEMENT DISORDERS. IT WAS REPORTED THAT REFERENCE FRAME HOLDER STRIPPED WHILE TIGHTENING THE REFERENCE FRAME. IT WAS UNKNOWN IF THE IT WAS CROSS THREADED OR IF THERE WAS A SLIGHT DEFECT IN THE SCREW PATTERN. A NEW NEXFRAME REFERENCE HOLDER WAS OPENED AND USED, THE ISSUE WAS RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP STATING THAT THE NEXFRAME WAS USED ON THE PATIENT FOR THE FIRST SIDE, BUT WHEN THEY USED IT ON THE SECOND SIDE THEY COULDN'T TIGHTEN IT ALL THE WAY SO A NEW NEXFRAME WAS USED. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9126066 ↗
• MalfunctionSep 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE SOCKET ASSEMBLY WAS ATTACHED TO THE NEXFRAME BASE AND THE SOCKET ASSEMBLY WOULD NOT MOVE FREELY. IT FELT AS IT SOMETHING WAS TOO TIGHT TO ALLOW MOVEMENT. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS WERE THOUGHT TO HAVE LED OR CONTRIBUTED TO THE ISSUE. THE THUMBSCREWS WERE LOOSER BUT THEY STILL CONTINUED TO HAVE THE SAME ISSUE. IT WAS REPORTED THEY OPENED UP A NEW KIT AND THE NEW SOCKET ASSEMBLY WORKED WELL. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO SURGICAL INFORMATION OCCURRED OR WAS PLANNED. THE PATIENT WAS ALIVE WITHOUT INJURY AT THE TIME OF THE REPORT AND NO COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7909911 ↗
• MalfunctionJul 2, 2018Device Operates Differently Than Expected; Insufficient Device Problem Information; Device Operates Differently Than Expected; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED DURING SURGERY THE CENTER MULTI LUMEN ADAPTER CANNULA HOLES WERE TIGHT. IT WAS HARD TO PUT THE CANNULAS DOWN A CERTAIN HOLE. THE SURGEON ROTATED THE ADAPTER AND USED A DIFFERENT HOLE. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. NO SURGICAL INTERVENTION OCCURRED OR WAS PLANNED. THE PATIENT WAS ALIVE WITHOUT INJURY AT THE TIME OF THE REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7655344 ↗
• MalfunctionApr 17, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEURO STIMULATOR (INS). IT WAS REPORTED THAT DURING SURGERY THE NEXFRAME ASSEMBLY WAS NOT MOVING SMOOTHLY WHEN THE DOCTOR WAS ADJUSTING IT. THERE WERE NO EXTERNAL ENVIRONMENTAL OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE THAT WERE REPORTED. THE DOCTOR CONTINUED TO TRY TO WORK WITH THE ORIGINAL ASSEMBLY BUT FELT IT WAS AFFECTING THEIR ABILITY TO BE ACCURATE. IT WAS REPORTED THAT THE NEXFRAME WAS REPLACED WITH A NEW ASSEMBLY KIT, THE NEW ASSEMBLY MOVED MORE SMOOTHLY THAN THE FIRST AND THE ISSUE WAS RESOLVED. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7435945 ↗
• MalfunctionOct 5, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE ABOUT A PATIENT WITH UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING STAGE 1 IMPLANT OF A DBS SYSTEM. THE BURR HOLE COVER WOULD NOT ENGAGE INTO THE BONE. THE STEREOTACTIC HEAD FRAME BASE WAS SECURED, BUT SEEMED TO BE VERY LOOSE AFTER IT WAS ALIGNED TO THE TARGET. THE SURGEON TRIED TIGHTENING THE BURR HOLE COVER SCREW MORE, BUT IT WOULD NOT ENGAGE. THE STEREOTACTIC HEAD FRAME SCREWS WOULD ALSO NOT TIGHTEN INTO THE BONE. THE BURR HOLE COVER SCREW WAS REPLACED, AND THE NEW SCREW WORKED WELL. THE STEREOTACTIC HEAD FRAME BASE WAS REPLACED WITH A NEW BASE USING AN EXTRA SCREW FROM THE FIRST BASE WHICH WOULDN'T TIGHTEN. THE EXTRA SCREW FROM THE FIRST BASE TIGHTENED INTO A RESCUE HOLE WITHOUT ISSUE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6917854 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012366. One submission often covers many models, so check the product and lot details in each record.

• Z-0849-2008 · Oct 4, 2007 · Terminated
  Nexframe Stereotactic System Kits, Model Number(s): DB-1021-MR, DB-1031, DB-1040-BL, DB-1040-ST, DB-1041, DB-1041-BL, DB-1041-ST, DB-1042, DB-1042-BL, DB-1042-ST, DB-1043, DB-1043-