EXPEDIUM 279702030NRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034388328), received between Dec 4, 2018 and May 8, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT AN INSTRUMENT BROKE INTRAOPERATIVELY WITH A 40MM FRAGMENT BEING STUCK IN THE PATIENT'S PEDICLE. BONE WAS DRILLED IN ATTEMPT TO RETRIEVE METAL, BUT SURGEON WAS NOT ABLE TO RETRIEVE IT, AND IT REMAINED INSIDE THE PATIENT. THIS RESULTED IN ONE EXTRA HOUR OF OPERATING TIME TO TRY TO REMOVE THE BROKEN FRAGMENT. THE PATIENT WILL NOT BE SUITABLE FOR AN MRI DUE TO THE STUCK METAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 21985494 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT A HANDFUL OF INSTRUMENTS WERE DAMAGED AND TAKEN OUT OF CIRCULATION. THESE INSTRUMENTS WERE TAKEN OUT OF CIRCULATION AS EARLY AS (B)(6) 2024 TO AS LATE AS (B)(6) 2024. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901195 ↗
• MalfunctionJan 26, 2023Break; Break

  VOLUNTARY REPORT RECEIVED (MW5104767) THORACIC STRAIGHT PROBE BROKE WHILE IN USE. BOTH PIECES RETRIEVED. USED A BROKEN SCREW REMOVAL SET TO REMOVE THE WORKING END FROM THE PATIENT'S BONE. SURGERY PROCEEDED AS PLANNED. THIS REPORT IS FOR ONE (1) THORACIC STRAIGHT PROBE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245679 ↗
• MalfunctionNov 9, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PROBE WAS BROKEN. THERE WAS NO PATIENT CONSEQUENCE AND NO DELAY IN SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM THORACIC PROBE, STRAIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15761031 ↗
• MalfunctionDec 3, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, AS PER MW5101850, SYNTHES/BRAINLAB PEDICLE FINDER BROKE WHILE IN USE. BOTH PIECES WERE RETRIEVED. THIS REPORT IS FOR ONE (1) THORACIC STRAIGHT PROBE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923337 ↗
• MalfunctionNov 1, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING A SPINAL FUSION SURGERY A PORTION OF THE THORACIC PEDICLE PROBE BROKE OFF AND REMAINED IN THE PATIENT'S SPINAL PEDICLE. THE SURGEON USED A BROKEN INSTRUMENT/SCREW REMOVAL TOOL TO EXTRACT THE BROKEN PIECE OF THE PROBE FROM THE PATIENT. THE BROKEN PORTION OF INSTRUMENT WAS REMOVED INTACT. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THERE WAS NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) THORACIC STRAIGHT PROBE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12727824 ↗
• MalfunctionOct 6, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS IT WAS REPORTED THAT ON (B)(6) 2021, A PROBE BROKE OFF 4CM DOWN THE SHAFT AND THE TIP WAS LODGED IN THE SACRUM OF THE PATIENT AND HAD TO USE A DRILL TO EXTRACT THE FRAGMENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIRTY(30) MINUTES OF SURGICAL DELAY. THIS REPORT IS FOR ONE (1) UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM THORACIC PROBE, STRAIGHT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12584836 ↗
• InjurySep 14, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: DURING A CASE ON (B)(6) 2021, IT WAS REPORTED THAT FOUR CENTIMETERS (4 CM) OF THE TIP OF THE INSTRUMENT BROKE OFF INSIDE THE PATIENT¿S HARD BONE AND WAS UN-RETRIEVABLE. THE PROCEDURE WAS COMPLETED WITH NO DELAY. THE PATIENT REPORTEDLY WENT HOME THE NEXT DAY AND IS DOING WELL. THERE IS NO PLAN TO REMOVE THE BROKEN PART IN THE FUTURE. THIS REPORT IS FOR A THORACIC STRAIGHT PROBE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12468059 ↗
• MalfunctionDec 4, 2018Break; Break

  THE FOLLOWING WAS REPORTED: (B)(4). DURING THE USED THE DEVICE BROKE AND A PIECE OF THE TIP REMAINED INTO THE PATIENT . THE SURGEON IS ASKING TO KNOW ASAP THE COMPONENT MATERIAL OF THE CODE (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8129079 ↗