iotaSOFT Insertion System IM-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00850002960068), received between Nov 29, 2024 and Mar 10, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Break

  IT WAS REPORTED TO THE COMPANY THAT AFTER A SUCCESSFUL CI ELECTRODE ARRAY PLACEMENT, DURING THE REMOVAL OF THE DRIVE UNIT BASE FROM ITS FIXATION (2 SELF-DRILLING SCREWS) ON THE SKULL ONE (1) OF THE SCREW HEADS SEPARATED FROM THE SHAFT DURING REMOVAL. THE SURGEON WAS ABLE TO REMOVE THE SCREW SHAFT IN ITS ENTIRETY AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24554479 ↗
• MalfunctionMar 10, 2026Break

  IT WAS REPORTED TO THE COMPANY THAT AFTER A SUCCESSFUL CI ELECTRODE ARRAY PLACEMENT, DURING THE REMOVAL OF THE DRIVE UNIT BASE FROM ITS FIXATION (2 SELF-DRILLING SCREWS) ON THE SKULL, BOTH SCREW HEADS SEPARATED FROM THE SHAFTS DURING THEIR REMOVAL. THE SURGEON WAS ABLE TO REMOVE BOTH SCREW SHAFTS IN THEIR ENTIRETY AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24554478 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED TO THE COMPANY THAT AFTER A SUCCESSFUL CI ELECTRODE ARRAY PLACEMENT, DURING THE REMOVAL OF THE DRIVE UNIT BASE FROM ITS FIXATION (2 SELF-DRILLING SCREWS) ON THE SKULL THE BONE SCREW HEADS SEPARATED FROM THE SHAFT DURING THEIR REMOVAL. THE SURGEON WAS ABLE TO REMOVE BOTH SCREW SHAFTS IN THEIR ENTIRETY AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24554415 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED TO THE COMPANY THAT AFTER A SUCCESSFUL CI ELECTRODE ARRAY PLACEMENT, THE BASE OF THE DRIVE UNIT WAS BEING REMOVED FROM ITS FIXATION (2 SELF-DRILLING SCREWS) ON THE SKULL AND ONE (1) OF THE SCREW HEADS SEPARATED FROM THE SHAFT DURING THE REMOVAL. AFTER ATTEMPTING TO REMOVE THE SHAFT OF THE SCREW, THE SURGEON DECIDED TO LEAVE THE SCREW IN THE SKULL. THE SURGICAL SITE WAS CLOSED AS USUAL WITH NO ADDITIONAL ISSUES REPORTED. THE SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY. THE BROKEN SCREW HEAD WAS RETURNED TO THE MANUFACTURER. THE COMPONENT (SCREW) IS UNDERGOING IN-HOUSE INSPECTION TO ASCERTAIN CAUSE OF SREW FAILURE. FOLLOW-UP STATUS ON PATIENT RECOVERY AND SAFE AND EFFECTIVE USE WITH IMPLANT WILL BE MONITORED. THE BONE SCREW IS MACHINED FROM TITANIUM TI 6AL 4V-ELI (ASTM F136 STANDARD SPECIFICATION FOR WROUGHT TITANIUM-6ALUMINUM-4VANADIUM ELI (EXTRA LOW INTERSTITIAL) ALLOY FOR SURGICAL IMPLANT APPLICATIONS) WHICH IS COMMONLY USED FOR IMPLANTS SUCH AS PLATE/SCREWS FOR BONE FIXATION. TITANIUM IS NON-MAGNETIC; THEREFORE, THE RISK OF ANY CI OR MRI INTERFERENCE IS MINIMAL. TITANIUM IS GENERALLY CONSIDERED SAFE AND COMPATIBLE WITH MRI AND DOES NOT INTERFERE SIGNIFICANTLY WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392474 ↗
• MalfunctionJan 16, 2025Break; Break

  IT WAS REPORTED TO THE COMPANY THAT AFTER A SUCCESSFUL CI ELECTRODE ARRAY PLACEMENT, THE BASE OF THE DRIVE UNIT WAS BEING REMOVED FROM ITS FIXATION (2 SELF-DRILLING SCREWS) ON THE SKULL AND ONE (1) OF THE SCREW HEADS SEPARATED FROM THE SHAFT DURING THE REMOVAL. THE SURGEON THEN REMOVED THE SCREW SHAFT WITH A NEEDLE DRIVER TO UNSCREW IT FROM THE SKULL AND WAS ABLE TO REMOVE THE SCREW SHAFT IN ITS ENTIRETY. SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY. THE BROKEN SCREW WAS RETURNED TO THE MANUFACTURER. NO PATIENT HARM REPORTED. FOLLOW-UP STATUS ON PATIENT RECOVERY AND SAFE AND EFFECTIVE USE WITH IMPLANT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173331 ↗
• MalfunctionNov 29, 2024Break; Break

  IT WAS REPORTED TO THE COMPANY THAT AFTER A SUCCESSFUL CI ELECTRODE ARRAY PLACEMENT, THE BASE OF THE DRIVE UNIT WAS BEING REMOVED FROM ITS FIXATION (2 SELF-DRILLING SCREWS) ON THE SKULL AND ONE (1) OF THE SCREW HEADS SEPARATED FROM THE SHAFT DURING THE REMOVAL. THE SURGEON DECIDED TO LEAVE THE SCREW IN THE SKULL AND USED THE DRILL TO SMOOTH DOWN ANY PROTRUSION OF THE SCREW. SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY. THE BROKEN SCREW HEAD WAS RETURNED TO THE MANUFACTURER. THE COMPONENT (SCREW) IS UNDERGOING IN HOUSE INSPECTION TO ASCERTAIN CAUSE OF SREW FAILURE. FOLLOW-UP STATUS ON PATIENT RECOVERY AND SAFE AND EFFECTIVE USE WITH IMPLANT WILL BE MONITORED. THE BONE SCREW IS MACHINED FROM TITANIUM TI 6AL 4V-ELI (ASTM F136 STANDARD SPECIFICATION FOR WROUGHT TITANIUM-6ALUMINUM-4VANADIUM ELI (EXTRA LOW INTERSTITIAL) ALLOY FOR SURGICAL IMPLANT APPLICATIONS) WHICH IS COMMONLY USED FOR IMPLANTS SUCH AS PLATE/SCREWS FOR BONE FIXATION. TITANIUM IS NON-MAGNETIC THEREFORE, THE RISK OF ANY CI OR MRI INTERFERENCE IS MINIMAL. TITANIUM IS GENERALLY CONSIDERED SAFE AND COMPATIBLE WITH MRI AND DOES NOT INTERFERE SIGNIFICANTLY WITH THE MAGNETIC FIELD OF THE MRI. IN ADDITION, THE SIZE OF THE BONE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20812304 ↗