EXPEDIUM 3010-19-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705034561455), received between Sep 21, 2023 and Apr 24, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DRIVER WAS FOUND TO BE BROKEN AND NEEDS TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21904973 ↗
• MalfunctionFeb 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENTS WERE WORN OUT. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21365519 ↗
• MalfunctionFeb 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENTS WERE WORN OUT. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21365499 ↗
• MalfunctionFeb 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENTS WERE WORN OUT. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21365476 ↗
• MalfunctionFeb 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENTS WERE WORN OUT. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364915 ↗
• MalfunctionJan 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS WERE WORN AND STRIPPED. SURGERY WAS COMPLETED SUCCESSFULLY USING THE INSTRUMENTS, AND THERE WAS NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105956 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING POST OP INSPECTION, IT WAS FOUND THAT INSTRUMENTS WERE BROKEN. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821520 ↗
• MalfunctionJul 17, 2024Break; Break

  IT WAS REPORTED THAT ON JUNE 21, 2024, UPON INSERTING THE 10X90 SCREW, THE T27 DRIVER BROKE DUE TO THE HIGH BONE QUALITY OF THE PATIENT. MULTIPLE DRIVERS BROKE INCLUDING THE MAJORITY OF THE T27 DRIVER INVENTORY AND THE T27 DRIVER BIT AS WELL TRYING TO BACK THE SCREW OUT SO THAT IT COULD TAP AND THEN ATTEMPT TO IMPLANT THE SCREW ONCE AGAIN. SURGEON WAS UNABLE TO REMOVE THE SCREW AND HAD TO UTILIZE A METAL CUTTING BURR TO CUT THE HEAD OFF THE SCREW AND BURR THE SCREW DOWN LEAVING THE MAJORITY OF THE SCREW SHANK IN THE PATIENT. SURGEON WAS ABLE TO UTILIZE THE NAVIGATION INSTRUMENTS AND GET ANOTHER SCREW IN TO PROVIDE AN ANCHOR ON THAT SIDE, AND THE SURGERY WAS SUCCESSFUL. SURGEON STATED THERE WAS NO CLINICAL SIGNIFICANCE OF THE SCREW BEING LEFT IN THE PATIENT, AND THAT THERE SHOULD BE NO CHANGE IN THE PATIENT'S PROJECTED OUTCOME. THIS REPORT IS FOR A 6.35 NAV DRIVER - SHAFT T27. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19766627 ↗
• MalfunctionJul 17, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, UPON INSERTING THE 10X90 SCREW, THE T27 DRIVER BROKE DUE TO THE HIGH BONE QUALITY OF THE PATIENT. MULTIPLE DRIVERS BROKE INCLUDING THE MAJORITY OF THE T27 DRIVER INVENTORY AND THE T27 DRIVER BIT AS WELL TRYING TO BACK THE SCREW OUT SO THAT IT COULD TAP AND THEN ATTEMPT TO IMPLANT THE SCREW ONCE AGAIN. SURGEON WAS UNABLE TO REMOVE THE SCREW AND HAD TO UTILIZE A METAL CUTTING BURR TO CUT THE HEAD OFF THE SCREW AND BURR THE SCREW DOWN LEAVING THE MAJORITY OF THE SCREW SHANK IN THE PATIENT. SURGEON WAS ABLE TO UTILIZE THE NAVIGATION INSTRUMENTS AND GET ANOTHER SCREW IN TO PROVIDE AN ANCHOR ON THAT SIDE, AND THE SURGERY WAS SUCCESSFUL. SURGEON STATED THERE WAS NO CLINICAL SIGNIFICANCE OF THE SCREW BEING LEFT IN THE PATIENT, AND THAT THERE SHOULD BE NO CHANGE IN THE PATIENT'S PROJECTED OUTCOME. THIS REPORT IS FOR A 6.35 NAV DRIVER - SHAFT T27. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19766604 ↗
• MalfunctionJul 17, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, UPON INSERTING THE 10X90 SCREW, THE T27 DRIVER BROKE DUE TO THE HIGH BONE QUALITY OF THE PATIENT. MULTIPLE DRIVERS BROKE INCLUDING THE MAJORITY OF THE T27 DRIVER INVENTORY AND THE T27 DRIVER BIT AS WELL TRYING TO BACK THE SCREW OUT SO THAT IT COULD TAP AND THEN ATTEMPT TO IMPLANT THE SCREW ONCE AGAIN. SURGEON WAS UNABLE TO REMOVE THE SCREW AND HAD TO UTILIZE A METAL CUTTING BURR TO CUT THE HEAD OFF THE SCREW AND BURR THE SCREW DOWN LEAVING THE MAJORITY OF THE SCREW SHANK IN THE PATIENT. SURGEON WAS ABLE TO UTILIZE THE NAVIGATION INSTRUMENTS AND GET ANOTHER SCREW IN TO PROVIDE AN ANCHOR ON THAT SIDE, AND THE SURGERY WAS SUCCESSFUL. SURGEON STATED THERE WAS NO CLINICAL SIGNIFICANCE OF THE SCREW BEING LEFT IN THE PATIENT, AND THAT THERE SHOULD BE NO CHANGE IN THE PATIENT'S PROJECTED OUTCOME. THIS REPORT IS FOR A 6.35 NAV DRIVER - SHAFT T27. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19766567 ↗
• MalfunctionMar 26, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE FINAL TIGHTENER IN QUESTION STRIPPED AT THE END OF THE CASE. THERE WAS NO HARM TO THE PATIENT OR DISRUPTION TO THE CASE. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A NAVIGATION ENABLED INSTRUMENTS EXPEDIUM DRIVER - SHAFT T27 6.35. THIS IS REPORT1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18978097 ↗
• MalfunctionJan 9, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE WORN DOWN TIP. NO PATIENT CONSEQUENCES WAS THERE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 6.35 NAV DRIVER - SHAFT T27. THIS IS REPORT 2 OF 3 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475118 ↗
• MalfunctionNov 7, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS DISCOVERED ON 10-19-2023 AFTER VISUAL INSPECTION THAT THE TIP OF THE 6.35 NAV DRIVER - SHAFT T27 WAS STRIPPED. THIS REPORT IS FOR ONE (1) 6.35 NAV DRIVER - SHAFT T27. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18083589 ↗
• MalfunctionSep 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON UNKNOWN DATE. IT IS UNKNOWN WHETHER THE IMPLANTS USED IN THE INITIAL SURGERY WERE J&J¿S PRODUCTS OR NOT. AFTER THE INITIAL SURGERY, A REOPERATION VIA A POSTERIOR FUSION (L3-S2) TO EXTEND FIXATION WAS PERFORMED ON (B)(6) 2023. A NAVIGATION-COMPATIBLE SAI INSTRUMENT SET WAS PREPARED FOR USE WITH THE O-ARM DURING SAI SCREW INSERTION. THE SURGEON ATTEMPTED TO ATTACH THE DRIVER SHAFT TO THE MEDTRONIC INSTRUMENT TO INSERT A SCREW INTO S2, BUT THE DRIVER SHAFT COULD NOT BE INSERTED INTO THE MEDTRONIC INSTRUMENT AND COULD NOT BE USED. OTHER TAPPING DEVICES WERE ATTACHED TO THE MEDTRONIC¿S INSTRUMENT AND ONLY THE DRIVER SHAFT COULD NOT BE ATTACHED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A NAVIGATION ENABLED INSTRUMENTS EXPEDIUM DRIVER - SHAFT T27 6.35. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17789061 ↗