EXPEDIUM 279702030Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10705034198439), received between Jun 23, 2017 and Aug 28, 2026 — classified as 4 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Break” (53 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 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50504567 ↗
• MalfunctionJun 10, 2026Break

  IT WAS REPORTED THAT THERE WAS A BROKEN TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25456890 ↗
• MalfunctionApr 22, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE PREPARATION OF A SCREW CHANNEL IN THE RIGHT ILIUM OS IN A DORSAL SPONDYLODESIS OF L1-ILIUM, INTRAOSSEOUS RUPTURE OCCURRED IN THE DISTAL THIRD OF THE TIP OF THE INSTRUMENT DURING THE UNWINDING OF THE INSTRUMENT (PEDICLE-AWL). THE TIP COULD NOT BE RECOVERED DUE TO THE VERY DEEP INTRAOSSEOUS POSITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24956434 ↗
• MalfunctionMar 9, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE PREPARATION OF A SCREW CHANNEL IN THE RIGHT ILIUM OS IN A DORSAL SPONDYLODESIS OF L1-ILIUM, INTRAOSSEOUS RUPTURE OCCURRED IN THE DISTAL THIRD OF THE TIP OF THE INSTRUMENT DURING THE UNWINDING OF THE INSTRUMENT (PEDICLE-AWL). THE TIP COULD NOT BE RECOVERED DUE TO THE VERY DEEP INTRAOSSEOUS POSITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24548102 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT WHEN CHECKING THE MODULE THE KEY WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476043 ↗
• 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 23453246 ↗
• MalfunctionSep 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, A THORACIC STRAIGHT PEDICLE PROBE HAD BROKEN INTO TWO PIECES. THE CURVED THORACIC PROBE HAD ALSO BEEN BENT AS THE PATIENT HAD EXTREMELY HARD BONE. THERE WAS NO ADVERSE EFFECT ON THE PATIENT OR OPERATION TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051910 ↗
• MalfunctionAug 11, 2025Break; Break

  IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE, THE XPDM THORACIC PEDICLE PROBE STRAIGHT BROKE OFF IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN MINUTE DELAY.

  Patient problems: Insufficient Information

  MAUDE report 22771936 ↗
• MalfunctionJul 23, 2025Break; Break

  IT WAS REPORTED THAT THE ITEM BROKE DURING A CASE. THE ITEM WAS DISPOSED OF BY THE SCRUB TEAM. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 22577453 ↗
• MalfunctionJun 26, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A SPINAL FUSION SURGERY, THE TIP OF THE PEDICLE PROBE (STRAIGHT) BROKE OFF AND REMAINED IN THE PATIENT. SURGERY WAS DELAYED BY 30 MINUTES DUE TO THE EVENT AND WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

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

  MAUDE report 22336080 ↗
• MalfunctionJun 16, 2025Break; Break

  IT WAS REPORTED THE EXPEDIUM THORACIC PROBE BROKE INTRAOPERATIVELY. THE PROBE WAS BEING USED CORRECTLY ¿ TO CREATE A CHANNEL THROUGH THE PEDICEL FOR SCREW INSERTION. THE DEVICE SNAPPED INTO TWO PIECES ¿ BOTH PIECES CONFIRMED AS REMOVED WITH NOTHING LEFT IN THE PATIENT. NO INJURY TO THE PATIENT, NO DELAY TO SURGERY, NO ADVERSE EVENT AS THERE WAS A SECOND KIT AVAILABLE IN THEATRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22215304 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 THE PEDICLE PROBE TIP BROKE OFF WHILE SURGEON WAS CANNULATING THE PEDICLE. TIP WAS EASILY REMOVED USING KERRISON FORCEPS AND NO HARM DONE TO PATIENT. CONTINUED SURGERY WITH A NEW PROBE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME REPORTED. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM THORACIC PEDICLE PROBE, STR. 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 19557350 ↗
• MalfunctionNov 2, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE TIP OF THE INSTRUMENT IS BROKEN. IT WAS MENTIONS PRE OP. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) XPDM THORACIC PEDICLE PRB, ST THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057858 ↗
• MalfunctionNov 1, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT DURING THE PROCEDURE, THE EXPEDIUM THORACIC PROBE BREAKS AT THE ENTRANCE OF THE PEDICLE WITHOUT CAUSING ANY HARM TO THE PATIENT. THERE WAS NO SURGICAL DELAY. FRAGMENTS WERE GENERATED BUT THEY WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE IS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) XPDM THORACIC PEDICLE PRB, ST THIS IS REPORT 1 OF 1 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049572 ↗
• InjuryMay 2, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE THORACIC PEDICLE PROBE GOT STUCK IN THE PEDICLE AND BROKE. THE SURGERY WAS DELAYED FOR 90 MINUTES, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE NOT GENERATED. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) XPDM THORACIC PEDICLE PRB, ST. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16852842 ↗
• MalfunctionMar 23, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE SURGERY TIP OF THE PEDICLE PROBE BROKE OFF AND WAS RETAINED IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM THORACIC PEDICLE PROBE, STR. 10-50MM PLUS OR MINUS 4.00 PERCENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600949 ↗
• MalfunctionFeb 22, 2023Break; Break

  THE TIMING OF THE REPORTED EVENT WAS POSTOPERATIVE. THE PATIENT WAS NOT AFFECTED BY THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16422819 ↗
• MalfunctionFeb 22, 2023Break; Break

  THE TIMING OF THE REPORTED EVENT WAS POSTOPERATIVE. THE PATIENT WAS NOT AFFECTED BY THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16422571 ↗
• MalfunctionJan 30, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE TIP FROM THE DEVICE WAS BROKEN. THERE WAS NO DELAY IN SURGERY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM THORACIC PEDICLE PROBE, STR. 10-50MM PLUS OR MINUS 4.00 PERCENT . THIS IS REPORT 1 OF 1 FOR (B)(4). THIS COMPLAINT INVOLVES ONE(1) DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16263526 ↗
• MalfunctionNov 28, 2022Break; Break

  IT WAS REPORTED THAT ON NOVEMBER 2, 2022, THE FOLLOWING ISSUES WERE DISCOVERED: THE TIP OF SCREWDRIVER WAS DEFECTIVE. AN MIS SLEEVE HAD A CLEANING ISSUE. THE TIP OF THORACIC PEDICLE PROBE BROKE OFF, NO FRAGMENT AVAILABLE. THE THREADED PIN FOR REPOSITIONING DOES NOT HOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15872097 ↗
• MalfunctionAug 23, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT WHILE PREPPING THE PEDICLE PATHWAY WITH A STRAIGHT THORACIC PEDICLE PROBE AT L5 ON THE LEFT SIDE, THE TIP BROKE OFF. THE INSTRUMENT MAY HAVE BEEN EXPERIENCING SOME FATIGUE AT THE JUNCTION OF THE TIP AND SHAFT. NO HARM WAS DONE AND A NEW INSTRUMENT WAS USED IN ITS PLACE. AS WELL, TWO EXPEDIUM REDUCTION INSTRUMENTS WERE NOT WORKING PROPERLY AS THE THREADS SEEMED TO BE STRIPPED AND WERE UNABLE TO THREAD INTO THE REDUCTION SLEEVE. OVER TIME THE THREADS AND THESE INSTRUMENTS DO WEAR DONE AND STRIP. THESE REDUCTION INSTRUMENTS HAVE BEEN IN CIRCULATION FOR A VERY LONG TIME AND ARE PROBABLY DUE TO BE REPLACED DUE TO REGULAR WEAR AND TEAR. SURGERY WAS NOT DELAY A REPLACEMENT INSTRUMENT WAS BROUGHT IN AND THE BROKEN INSTRUMENT WAS SET ASIDE. , THE SURGERY WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE NOT GENERATED. THERE WAS NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) XPDM THORACIC PEDICLE PRB, ST. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15278381 ↗
• MalfunctionJul 12, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE TIP OF THE DEVICE BROKE OFF DURING CLEANING PROCESS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) XPDM THORACIC PEDICLE PRB, ST. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14986102 ↗
• 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, STR. 10-50MM PLUS OR MINUS 4.00 PERCENT. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14597295 ↗
• InjuryDec 3, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING CANNULATION OF THE RIGHT-SIDED L5 PEDICLE THE GEARSHIFT PROBE BROKE IN HALF. THIS RESULTED IN PUNCTURING OF THE DURA. THE DUROTOMY SITE WAS IRRIGATED COPIOUSLY. THE NERVE ROOTS WERE GENTLY MANIPULATED AND PLACED BACK INSIDE THE DURA, PADDED WAS USED TO MAINTAIN THIS IN PLACE. THE DUROTOMY WAS CLOSED WITH 4-0 NUROLON WITH A WATERTIGHT SEAL. A VALSALVA WAS PERFORMED TO ENSURE THIS WATERTIGHT SEAL. WE THEN USE DURA SEAL TO SEAL THE DUROTOMY SITE STATUS POST REPAIR AS WELL AS THE ANNULOTOMY AND BONE GRAFT IN THE DISC SPACE. AGAIN, WE COPIOUSLY IRRIGATED THE WOUND WITH NORMAL SALINE. A SUBFASCIAL DRAIN WAS PLACED INTO THE WOUND. THE FASCIA WAS CLOSED IN INTERRUPTED FASHION WITH 0 VICRYL SUTURE FOLLOWED BY SUBCUTANEOUS 2-0 VICRYL SUTURES AND SUBCUTICULAR RUNNING QUILL. THIS WAS FOLLOWED BY DERMABOND, STERI-STRIPS AND AL AN ISLAND DRESSING. PATIENT WAS TRANSFERRED BACK TO HIS HOSPITAL BED AND EXTUBATED WITHOUT DIFFICULTY. HE WAS TRANSFERRED TO THE POST ANESTHESIA CARE UNIT IN STABLE CONDITION. MRI WAS OBTAINED BY THE ADMITTING SERVICE WHICH DEMONSTRATED SEVERE SPINAL STENOSIS AT L3-L4 AND L4-L5 WITH INSTABILITY AT L4-L5. ORTHOPEDIC SURGERY WAS C

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12923428 ↗
• MalfunctionNov 18, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, A PROBE BROKE DURING PEDICULATION. THE BROKEN TIP COULD BE REMOVED AND WAS DISCARDED. NO PARTS REMAIN IN PATIENT. PROCEDURE WAS COMPLETED WITH NO SIGNIFICANT DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM THORACIC PEDICLE PROBE, STR. 10-50MM PLUS OR MINUS 4.00 PERCENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12838029 ↗