EXPEDIUM 279702040Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705034198446), received between Jun 23, 2017 and Feb 25, 2026 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Break

  KEY CAME INSIDE THE MODULE BROKEN. THERE WAS NO PATIENT OR USER DAMAGE. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444767 ↗
• MalfunctionNov 13, 2025Break; Break

  THE PEDICLE PROBE BROKE DURING INSERTION INTO THE PATIENT DURING SURGERY. THEY MANAGED TO RETRIEVE THE BROKEN PART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23546899 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT A VERY COMPLICATED PATIENT HAD VERY HARD BONE THAT BROKE SEVERAL INSTRUMENTS DURING THE PROCEDURE. THERE WERE NO SURGERY DELAYED DUE TO THE REPORTED EVENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452969 ↗
• MalfunctionOct 23, 2025Break; Break

  IT WAS REPORTED THAT THE PROBE BROKE DURING USE IN SURGERY. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368716 ↗
• MalfunctionMar 24, 2025Break; Break

  IT WAS REPORTED THAT THE ITEM BROKEN INTRAOPERATIVELY. THERE WAS NO PATIENT HARM. ALL FRAGMENTS WERE REMOVED FROM PATIENT. THERE WAS A FIVE-MINUTE SURGICAL DELAY, AND THE OPERATION WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676356 ↗
• MalfunctionNov 4, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A PRE OPERATIVE EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20597953 ↗
• MalfunctionJun 6, 2023No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A BLIND UNIT WAS RECEIVED IN LOCAL STOCK MARKED WITH RED TAPE. UPON MANUFACTURER INVESTIGATION IT WAS DETERMINED THAT A PEDICLE PROBE HAD A BROKEN TIP AND A DEROTATION STICK HAD ONE OF ITS CLAMP YOKES BROKEN OFF. THIS REPORT IS FOR A XPDM THORACIC PEDICLE PRB, CRV. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17073460 ↗
• MalfunctionApr 19, 2023Break; Break

  DEVICE REPORT FROM PORTUGAL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023, THE PROBE IN QUESTION BROKE WHILE THE SURGEON WAS INTRODUCING IT INTO THE PEDICLE. NO FRAGMENTS WERE GENERATED, THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM THORACIC PEDICLE PROBE, CURV. 10-50MM PLUS OR MINUS 4.00%. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16771001 ↗
• MalfunctionSep 8, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PEDICLE FINDER BROKE WHILE THE SURGEON WAS TRYING TO CREATE A HOLE IN THE SACRUM FOR SCREW PLACEMENT. THE BROKEN PIECE WAS RETRIEVED AND THERE WAS NO OTHER INCIDENT. ANOTHER PEDICLE FINDER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM THORACIC PEDICLE PROBE, CURV. 10-50MM PLUS OR MINUS 4.00 PERCENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15381659 ↗
• MalfunctionJun 3, 2022Break; Material Deformation; Material Twisted/Bent; Break; Material Deformation; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HOSPITAL HAS PUT ASIDE VARIOUS EXPEDIUM INSTRUMENTS THAT WERE STARTING TO SHOW WEAR AND TEAR FROM LONG TERM USE. THE INSTRUMENTS WERE TAKEN FROM SETS AND OUT OF CIRCULATION IF DEEMED NO LONGER USABLE DUE TO BENDS, BREAKAGE, MALFORMATION, STRIPPING ETC. THERE HAVE BEEN NO ADVERSE EVENTS OR IMPACT TO THE PATIENT WITH THESE INSTRUMENTS. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM THORACIC PEDICLE PROBE, CURV. 10-50MM PLUS OR MINUS 4.00 PERCENT. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14597263 ↗
• MalfunctionAug 16, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE THE SURGEON WAS USING THE GEAR SHIFT TO PROBE THE PEDICLE SCREWS WHEN THE TIP OF THE GEAR SHIFT BROKE OFF INTO THE PATIENT AT T1. THE SURGEON WAS ABLE TO REMOVE THE BROKEN PIECE AND INSERT THE PEDICLE SCREW WITHOUT ANY FURTHER PROBLEMS. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR A GEAR SHIFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12327960 ↗
• MalfunctionMar 25, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING SPINAL FUSION PROCEDURE AS THE SURGEON WAS USING THE PEDICLE PROBE TO CANNULA THE PEDICLE, THE DISTAL END OF THE INSTRUMENT BROKE OFF INSIDE THE PEDICLE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. ADDITIONAL DISSECTION WAS REQUIRED TO EXPOSE FRAGMENT AND PITUITARY USED TO GRAB AND REMOVE FRAGMENT. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) XPDM THORACIC PEDICLE PRB, CRV. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11568516 ↗
• MalfunctionFeb 8, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE DEVICES BROKE DOWN DURING THE SURGICAL PROCEDURE. THE DEVICES DID NOT GENERATE ANY FRAGMENTS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED TO BE OPTIMAL CONDITION. CONCOMITANT DEVICES REPORTED: HANDLES (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 2); X25 FINAL TIGHTENER (PART NUMBER 279712600, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM THORACIC PEDICLE PROBE, CURV. 10-50MM PLUS OR MINUS 4.00 PERCENT. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11292583 ↗
• MalfunctionOct 2, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING L1-L2 DECOMPRESSION 7 L4-L5 SURGERY, THE THORACIC PEDICLE PROBE BROKE. THERE WAS NO SURGICAL DELAY. FRAGMENTS WERE GENERATED AND EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) XPDM THORACIC PEDICLE PRB, CRV. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10621420 ↗
• MalfunctionAug 15, 2019Break; Break

  BROKEN 279702040. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? YES. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8896333 ↗
• MalfunctionJun 17, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A POSTERIOR SPINAL FUSION ON A PATIENT WITH HARD BONE, WHILE CREATING A PATHWAY FOR THE SCREW INTO THE PEDICLE, THE THORACIC PROBE BROKE AT THE DISTAL END TIP. THIS PIECE WAS RETRIEVED AND NOTHING WAS LEFT INSIDE THE PATIENT. ALSO, WHEN DOING FINAL TIGHTENING, THE TORQUE DRIVER SHAFT STRIPPED AT THE DISTAL END TIP. THERE WERE FRAGMENTS GENERATED BUT WAS EASILY REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT DID NOT SUFFER DUE TO THESE BRAKES. CONCOMITANT DEVICE REPORTED: UNKNOWN POLYAXIAL SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8705160 ↗
• MalfunctionMar 14, 2019Break; Break

  IT WAS REPORTED THAT THE TIP OF THE PEDICLE PROBE BROKE. IT IS A OLD INSTRUMENT. IT HAPPENED DURING SURGERY, NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8422211 ↗
• InjuryJan 22, 2019Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, DR. (B)(6) WAS USING THE EXPEDIUM PEDICLE PROBE TO PREPARE THE PEDICLE FOR SCREW INSERTION INTO THE LEFT SIDE OF S1 (SACRAL 1). HE HAD JUST COMMENTED HOW HARD THE PATIENT'S BONE WAS DURING INSERTION OF OTHER SCREWS. AT THIS TIME THE DISTAL END OF THE PROBE SNAPPED OFF. HE WAS ABLE TO EASILY RECOVER BROKEN FRAGMENT, BUT A SMALL DURAL TEAR WAS CREATED. HE HAD TO COMPLETE A DURAL REPAIR WITH SUTURE AND FIBRIN SEALANT. PART NUMBER: 297-02-040, LOT #: NW140086. WAS IT DELAYED? YES. HOW LONG? 20MIN. ACTION TAKEN - DURAL REPAIR - REPLACEMENT OF BROKEN INSTRUMENT. WAS PROCEDURE COMPLETED? YES. FRAGMENTS: YES. EASILY REMOVED: YES. PATIENT "CONSEQUENSES": UNKNOWN. OTHER MEDICAL INTERVENTION: DURAL REPAIR

  Patient problems: Excessive Tear Production; Spinal Cord Injury

  MAUDE report 8267941 ↗
• MalfunctionJun 26, 2018Break; Break

  THE TIP OF THE INSTRUMENT BROKE WHILE THE SURGEON WAS ATTEMPTING TO MAKE A HOLE IN THE PEDICLE. THE BROKEN PIECE WAS REMOVED WITHOUT INCIDENT. A NO CHARGE REPLACEMENT WILL BE NEEDED. PO TO FOLLOW SHORTLY. 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 7637527 ↗
• InjuryMar 21, 2018Break; Break

  WHILE INSERTING THE EXPEDIUM THORACIC PROBE INTO THE L5 PEDICLE THE TIP OF THE PROBE BROKE OFF INTO THE PEDICLE. ABOUT 20 MM. THE SURGEON HAD TO DRILL OUT THE PEDICLE IN ORDER TO RETRIEVE THE TIP. ALSO WHILE INSERTING A PEDICLE SCREW THE TIP OF THE EXPEDIUM POLY DRIVER BROKE OFF INTO THE TULIP,OF THE SCREW. THE TIP WAS NOT ABLE TO BE RETRIEVED. IT REMAINS IN THE SCREW. PATIENT CONSEQUENCE?: YES. PATIENT CONSEQUENCE DESCRIPTION:ADDITIONAL EXPOSURE TO ANESTHESIA PLUS THE L5 PEDICLE WAS ALMOST NOT A VIABLE FIXATION POINT. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: Injury; Not Applicable

  MAUDE report 7357090 ↗
• MalfunctionJun 23, 2017Break; Break

  THERE ARE 100+ ITEMS PLACED ON DC ORTHOKIT QUARANTINE DUE TO BREAKAGES, FUNCTIONAL TESTS FAILURES. THIRTY EIGHT PERTAIN TO DEPUY SPINE PRODUCTS. IN ALL CASES NO DATA AVAILABLE IF ANY INJURES OR ADVERSE EVENTS. NO INFORMATION ABOUT SURGERY, DELAYS, PATIENT RELATED DATA. ONLY PRODUCT CODE/LOT DESCRIPTION AND BREAKAGE DEFINITION IS AVAILABLE. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6663347 ↗