EXPEDIUM 279712590Recalls & reported problems
Medos International Sàrl · EXPEDIUM SPINE SYSTEM SINGLE INNER INSERTER 5.5mm · Class 1
All models of EXPEDIUM (291)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medos EXPEDIUM spine system inner inserter, a surgical tool used during spinal fusion procedures. The 38 reports mostly describe the instrument failing to grip or hold properly during surgery, along with parts breaking, jamming, or bending, and sometimes a piece coming loose. No deaths or injuries are reported, and most cases finished without delay or harm to the patient. No recalls name this device, and reports have dropped from 10 in the prior12 months to none in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10705034199016), received between Dec 19, 2017 and Oct 24, 2025 — classified as 38 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (21 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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility21
- Break9
- Mechanical Jam8
- Detachment of Device or Device Component1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- No Consequences Or Impact To Patient3
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ITEMS DID NOT HOLD ANYMORE DURING A SPINAL FUSION PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379947 ↗MalfunctionOct 24, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ITEMS DID NOT HOLD ANYMORE DURING A SPINAL FUSION PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379946 ↗MalfunctionOct 24, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ITEMS DID NOT HOLD ANYMORE DURING A SPINAL FUSION PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379945 ↗MalfunctionOct 24, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ITEMS DID NOT HOLD ANYMORE DURING A SPINAL FUSION PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379943 ↗MalfunctionOct 24, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ITEMS DID NOT HOLD ANYMORE DURING A SPINAL FUSION PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379942 ↗MalfunctionOct 24, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ITEMS DID NOT HOLD ANYMORE DURING A SPINAL FUSION PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379936 ↗MalfunctionOct 24, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ITEMS DID NOT HOLD ANYMORE DURING A SPINAL FUSION PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379935 ↗MalfunctionOct 24, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ITEMS DID NOT HOLD ANYMORE DURING A SPINAL FUSION PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379934 ↗MalfunctionJun 10, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO FRAGMENTS WERE GENERATED. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO REVISION OR REMOVAL SURGERY REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22177237 ↗MalfunctionApr 2, 2025Break; Break
IT WAS REPORTED THAT THE TIP HAS BROKEN OFF WHEN INSERTING SI. THERE WAS NO DELAY. PATIENT WAS NOT AT RISK. NO BROKEN FRAGMENTS WERE RETAINED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21755691 ↗MalfunctionSep 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024, ONE REDUCER DID NOT ATTACH ANYMORE AND THE OTHER ONE FELL APART. A SECOND INSTRUMENT WAS AVAILABLE THAT WAS ABLE TO BE USED. THERE WAS NO PATIENT IMPACT, AND THE SURGERY TIME WAS NOT EXTENDED. FRAGMENTS WERE EASILY REMOVED, AND IT WAS REPORTED THAT EVERYTHING WAS OKAY WITH THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20191134 ↗MalfunctionMay 20, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE FLEX CLIP REDUCER INSERTER GOT STUCK INSIDE THE FLEX CLIP WHILST ATTACHED TO THE SCREW AND NOT ALLOWING NEITHER TO REDUCE OR RELEASE. SURGEON HAD TO FORCE THE INSTRUMENT TO DETACH IT FROM THE SCREW. THIS ACTION RESULTED IN A PULL OUT OF THE SCREW AND FORCED TO INSERT A WIDER SCREW. THERE WAS THIRTY (30) MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) UNKNOWN SCREW THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4)>
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19353166 ↗MalfunctionMar 14, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE INNER DISTAL PART OF THE INSERTER DOES NOT ROTATE WHEN THE SCREWDRIVER IS TURNED. THE SET SCREW COULD NOT BE SCREWED IN WHEN TURNED AS THE INNER PART IS STATIONARY IN THE SCREWDRIVER AND ONLY THE OUTER PART ROTATES. SURGERY WAS NOT DELAYED. THE PATIENT STATUS IS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME. THIS REPORT IS FOR ONE APPROXIMATOR FC INSERTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT . (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18902746 ↗MalfunctionJan 25, 2024Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE. YES - SURGERY WAS COMPLETED SUCCESSFULLY WITH NO ISSUES. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) APPROXIMATOR FC INSERTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18578847 ↗MalfunctionOct 12, 2023Break; Break
IT WAS REPORTED ON (B)(6) 2023, THAT DURING A TRAUMA CASE THE SET CAP INSERTER¿S SPRING WAS FOUND TO BE FAULTY. THE BENT THORACIC PROBE WAS ALSO BENT DURING THE PROCEDURE, WE HAD A SECOND SO IT WAS OKAY, THE FELLOW TRIED TO BEND THE OTHER ONE BACK INTO PLACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WERE NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) APPROXIMATOR FC INSERTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17919273 ↗MalfunctionMay 31, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2023, THE INSERTER WAS SEPARATED FROM THE TUBE OF THE DEVICE IN QUESTION (279712580) AND A SET SCREW WAS ATTACHED. THE INSERTER WAS ULTIMATELY NOT UTILIZED DURING THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE PROCEDURE DURING CLEANUP, THE INSERTER WAS INSERTED INTO THE TUBE WITH THE SET SCREW STILL ATTACHED. THE SET SCREW GOT CAUGHT IN THE SPRING SECTION OF THE TUBE AND COULD NOT BE REMOVED. THE EVENT OCCURRED AFTER THE PROCEDURE, THERE WAS NO PATIENT IMPACT. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SINGLE INNER INSERTER 5.5MM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17030369 ↗MalfunctionMay 9, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2023, THE APPROXIMATOR CAN NO LONGER BE SCREWED INTO THE FLEX GUIDE. THE INSTRUMENTS CAN NO LONGER BE USED. THERE WAS NO PATIENT INVOLVEMENT OR SURGERY DELAY. THIS REPORT IS FOR ONE (1) APPROXIMATOR FC INSERTER THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16899303 ↗MalfunctionFeb 6, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023 THAT DURING REDUCTION MANEUVERS, THE INTERNAL REDUCTION GEAR SYSTEM IS BLOCKED. IT DOES NOT PASS THE REDUCER INSIDE THE CLIP. THE SURGERY ENDS WITHOUT PROBLEMS AND WITHOUT AFFECTING THE PATIENT. THIS REPORT IS FOR ONE (1) APPROXIMATOR FC INSERTER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16303304 ↗MalfunctionOct 19, 2022Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER NO LONGER HELD THE X25 INSERT CAPS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SINGLE INNER INSERTER 5.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15633842 ↗MalfunctionJun 6, 2022Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THE SCRUB NURSE WAS PUTTING TOGETHER THE MODIFIED REDUCERS (FROM THE LOAN MODIFIED EXPEDIUM 5.5 REDUCTION SLEEVE TRAY) AT THE BEGINNING OF THE CASE AND THE REDUCER X25 DRIVER BECAME STUCK MID WAY DOWN THE REDUCTION SLEEVE. IN TOTAL THERE WERE 4 PAIRS THAT BECAME STUCK. SCRUB NURSE WAS UNABLE TO REMOVE THEM. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) APPROXIMATOR FC INSERTER. THIS IS REPORT 4 OF 8 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14600634 ↗MalfunctionJun 6, 2022Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THE SCRUB NURSE WAS PUTTING TOGETHER THE MODIFIED REDUCERS (FROM THE LOAN MODIFIED EXPEDIUM 5.5 REDUCTION SLEEVE TRAY) AT THE BEGINNING OF THE CASE AND THE REDUCER X25 DRIVER BECAME STUCK MID WAY DOWN THE REDUCTION SLEEVE. IN TOTAL THERE WERE 4 PAIRS THAT BECAME STUCK. SCRUB NURSE WAS UNABLE TO REMOVE THEM. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) APPROXIMATOR FC INSERTER. THIS IS REPORT 5 OF 8 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14600631 ↗MalfunctionJun 6, 2022Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THE SCRUB NURSE WAS PUTTING TOGETHER THE MODIFIED REDUCERS (FROM THE LOAN MODIFIED EXPEDIUM 5.5 REDUCTION SLEEVE TRAY) AT THE BEGINNING OF THE CASE AND THE REDUCER X25 DRIVER BECAME STUCK MID WAY DOWN THE REDUCTION SLEEVE. IN TOTAL THERE WERE 4 PAIRS THAT BECAME STUCK. SCRUB NURSE WAS UNABLE TO REMOVE THEM. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE APPROXIMATOR FC INSERTER. THIS IS REPORT 3 OF 8 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14600630 ↗MalfunctionJun 6, 2022Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THE SCRUB NURSE WAS PUTTING TOGETHER THE MODIFIED REDUCERS (FROM THE LOAN MODIFIED EXPEDIUM 5.5 REDUCTION SLEEVE TRAY) AT THE BEGINNING OF THE CASE AND THE REDUCER X25 DRIVER BECAME STUCK MID WAY DOWN THE REDUCTION SLEEVE. IN TOTAL THERE WERE 4 PAIRS THAT BECAME STUCK. SCRUB NURSE WAS UNABLE TO REMOVE THEM. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) APPROXIMATOR FC INSERTER THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14600629 ↗MalfunctionJun 3, 2022Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE INSERTER WAS DISASSEMBLED IN THE PREOPERATIVE STERILIZATION. THE NURSE MISTAKENLY HANDED THE INSERTER TO THE SURGEON WITHOUT ASSEMBLING THE TUBE AND INSERTER COMPONENTS. A SETSCREW BECAME STUCK IN THE TUBE COMPONENT. NO PRODUCT DEFECTIVENESS WAS INVOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM SINGLE INNER INSERTER 5.5MM. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14596699 ↗MalfunctionMay 19, 2022Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING SPINAL FUSION PROCEDURE, THE SCRUB NURSE WAS PUTTING THE REDUCER X25 DRIVER INSIDE THE REDUCTION SLEEVE AND IT BECAME STUCK. IT COULD NOT BE ROTATED OR REMOVED FROM THE REDUCTION SLEEVE. THESE TWO ITEMS WERE PUT TO THE SIDE AND NOT USED DURING THE CASE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE APPROXIMATOR FC INSERTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14438322 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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