EXPEDIUM 279702010Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034198415), received between Dec 19, 2017 and Oct 24, 2025 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 24, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED ON AN UNKNOWN DATE THAT A STRAIGHT LUMBAR PROBE FROM THE EXPEDIUM PRODUCT FAMILY¿S TIP BROKE OFF INTRAOPERATIVELY. SURGERY WAS DELAYED DUE TO RELATED INCIDENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. FRAGMENTS WAS GENERATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23381385 ↗
• MalfunctionJul 15, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE SURGEONS WERE MAKING THEIR PEDICLE HOLE WITH THE STRAIGHT PEDICLE FINDER. THE PATIENT'S BONE WAS VERY HARD AND AFTER SEVERAL HOLES, THE FINDER WAS BENT. THEY ATTEMPTED TO STRAIGHTEN THE FINDER AT WHICH POINT IT SNAPPED. A REPLACEMENT FROM ANOTHER TRAY IN THE HOSPITAL WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A MINIMAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THIS REPORT IS FOR AN XPDM PEDICLE PROBE, STRAIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19740120 ↗
• MalfunctionFeb 27, 2024Break; Break

  THERE WAS PATIENT INVOLVEMENT. BROKEN PIECES RETRIEVED, NO ADVERSE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18787212 ↗
• MalfunctionSep 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT DURING SURGERY AND INERTION OF THE PROBE IN THE PEDICLE, THE PROBE BENDT. SAME LIKE PRODUCT WAS USED. THERE WAS NO SURGICAL DELAY. PATIENT WAS INVOLVED BUT NO HARM WAS DONE ON THE PATIENT. THIS REPORT IS FOR ONE (1) XPDM PEDICLE PROBE, STRAIGHT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15413676 ↗
• InjuryJun 27, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED ON (B)(6) 2022, DURING LUMBAR FUSION PROCEDURE, WHILE USING THE PEDICLE PROBE OUT OF THE EXPEDIUM OFFSET INSTRUMENTS, THE INSTRUMENT BROKE INTRAOPERATIVELY. THE SURGEON TOOK A X-RAY TO SEE THE FRAGMENT, THE TIP OF THE DEVICE ABOUT 1 CM LONG EMBEDDED IN THE PATIENT. THE DECISION WAS MADE BY SURGEON TO LEAVE THE BROKEN TIP IN AND PLACE THE PEDICLE SCREW IN NEXT TO THE BROKEN PART. FRAGMENTS WERE GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS FINE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A PEDICLE PROBE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14833345 ↗
• InjurySep 14, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE TIP OF THE AWL BROKE OFF. THE BROKEN OFF DISTAL PART OF THE AWL REMAINED IN THE BONE NEAR THE PROMONTORIUM. A SCREW IN A SLIGHTLY HIGHER CONVERGENCE COULD BE PLACED NEXT TO THE BROKEN OFF PART OF THE AWL WITHOUT ANY PROBLEMS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS GOOD. THIS REPORT IS FOR AN EXPEDIUM PEDICLE PROBE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12468033 ↗
• InjuryMay 30, 2018Break; Break

  SURGEON WAS USING THE STRAIGHT, BLUNT PEDICLE PROBE TO MAKE A SCREW TRACK AND THE PROBE BROKE OFF INTO THE VERTEBRAL BODY OF L5 ON THE LEFT SIDE. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION: INCREASED ANESTHESIA TIME AND BLOOD LOSS. PART OF THE BROKEN PEDICLE PROBE WAS RETAINED IN THE PATIENT. SURGEON HAD TO EXTEND THE FUSION 1 LEVEL, WHICH WAS NOT PLANNED. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Blood Loss; Foreign Body In Patient; Injury; Local Reaction; Not Applicable

  MAUDE report 7553385 ↗
• MalfunctionMay 16, 2018Break; Break

  THE TIP OF THE INSTRUMENT BROKE WHILE THE SURGEON WAS TRYING TO MAKE A HOLE IN THE VERTEBRA. IT WAS VERY HARD BONE AND IT BROKE AS THE INSTRUMENT WAS BEING TWISTED. THE BROKEN PIECE WAS DISCARDED BUT THE INSTRUMENT ITSELF WILL BE RETURNED. A REPLACEMENT INSTRUMENT WILL BE NEEDED AND IT SHOULD BE SHIPPED TO THE ACCOUNT USING THE NO CHARGE PO #(B)(4). PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7519910 ↗
• MalfunctionDec 19, 2017Break; Break

  FEELER PROBE TIP BROKE OFF IN PEDICLE. RETRIEVED AND SURGERY PROCEEDED. PATIENT CONSEQUENCE? NO. ACTION TAKEN FOR PROCEDURE: RETRIEVED BROKEN PIECE. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7130792 ↗