EXPEDIUM 279712570Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10705034198996), received between Apr 13, 2020 and Jun 16, 2026 — classified as 1 injury, 44 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (36 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION ON MAY 21, 2026. AFTER THE PROCEDURE WAS COMPLETE, AND NURSING WAS BEGINNING TO CLEAN UP BACK TABLE, THEY NOTED THAT THEY WERE UNABLE TO REMOVE A 'TURN DOWN' FROM THE 'CLIP.' THE TURN DOWN WAS THREADED INTO THE CLIP, AND NO STAFF OR SURGEON, OR COMPANY REPRESENTATIVE, WAS ABLE TO UNTHREAD IT FROM THE CLIP. IT WAS COMPLETELY JAMMED/STUCK. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WERE NO DEVICE FRAGMENTS AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25519427 ↗
• MalfunctionJun 15, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT APPROXIMATOR FLEX-CLIP AND APPROXIMATOR FC SLEEVE WERE INVOLVED IN AN EVENT DURING A SPINAL FUSION PROCEDURE. AFTER THE PROCEDURE WAS COMPLETED, NURSING STAFF DISCOVERED THAT THE 'TURN DOWN' COULD NOT BE REMOVED FROM THE 'CLIP' AS IT WAS COMPLETELY JAMMED AND COULD NOT BE UNTHREADED BY STAFF, THE SURGEON, OR A COMPANY REPRESENTATIVE. THE SURGERY WAS NOT DELAYED, THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND NO FRAGMENTS WERE GENERATED. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT, AND NO OBSERVABLE CLINICAL SYMPTOMS OR ADDITIONAL MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505628 ↗
• MalfunctionDec 16, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THE INSTRUMENT MALFUNCTIONED WHILE BEING USED IN A PROCEDURE. THREE CLIPS KEPT ON SLIPPING OFF THE SCREW HEAD DURING USE. THERE WAS NO DAMAGE OR DELAY CAUSED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816841 ↗
• MalfunctionDec 16, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THE INSTRUMENT MALFUNCTIONED WHILE BEING USED IN A PROCEDURE. THREE CLIPS KEPT ON SLIPPING OFF THE SCREW HEAD DURING USE. THERE WAS NO DAMAGE OR DELAY CAUSED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816840 ↗
• MalfunctionDec 16, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THE INSTRUMENT MALFUNCTIONED WHILE BEING USED IN A PROCEDURE. THREE CLIPS KEPT ON SLIPPING OFF THE SCREW HEAD DURING USE. THERE WAS NO DAMAGE OR DELAY CAUSED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816829 ↗
• MalfunctionNov 6, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SCREWDRIVER STRIPPED AND FLEX CLIP WAS BENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486135 ↗
• MalfunctionJun 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE APPROXIMATOR SLEEVE WOULD NOT ADVANCE IN FLEX CLIP FOR SCOLIOSIS REDUCTION. TWO APPROXIMATOR SLEEVED FULLY JAMMED INTO FLEX CLIP. THREE APPROXIMATOR SLEEVES WOULD NOT ROTATE INTO FLEX CLIP. ON FURTHER INSPECTION - THE DISTAL TIP OF APPROXIMATOR SLEEVE X 3 WOULD NOT ROTATE. THE BEARINGS WERE COMPLETELY JAMMED. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. OTHER APPROXIMATOR SLEEVES WERE USED. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177872 ↗
• MalfunctionSep 25, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE REDUCTION SLEEVE WAS BENT, CLIP WOULD NOT SEAT PROPERLY, THE INSERTER'S SHAFT WAS BENT, THE SCREWDRIVER WAS STRIPPED, AND THE PROBE WAS BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304278 ↗
• MalfunctionSep 25, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE REDUCTION SLEEVE WAS BENT, CLIP WOULD NOT SEAT PROPERLY, THE INSERTER'S SHAFT WAS BENT, THE SCREWDRIVER WAS STRIPPED, AND THE PROBE WAS BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT IS RELATED TO PC-001704852 WHICH CAPTURES ADDITIONAL PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304206 ↗
• MalfunctionSep 25, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE REDUCTION SLEEVE WAS BENT, CLIP WOULD NOT SEAT PROPERLY, THE INSERTER'S SHAFT WAS BENT, THE SCREWDRIVER WAS STRIPPED, AND THE PROBE WAS BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20303807 ↗
• MalfunctionSep 9, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED ON AUGUST 13, 2024, SEVERAL EXPEDIUM INSTRUMENTS WERE BROKEN OR HAD A MALFUNCTION. THE STRAIGHT PROBE HAD A TIP BENT. THE STRAIGHT FEELER WAS BROKEN. A TORQUE DRIVER TIP WAS STRIPPED. A REDUCER, CLIP AND SLEEVE HAD THREADS STRIPPED AND BOTH PIECES STUCK TOGETHER. NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. NEW DEVICES PROVIDED. THIS REPORT IS FOR ONE FLEX-CLIP FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20172256 ↗
• MalfunctionSep 9, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2024, SEVERAL EXPEDIUM INSTRUMENTS WERE BROKEN OR HAD A MALFUNCTION. THE STRAIGHT PROBE HAD A TIP BENT. THE STRAIGHT FEELER WAS BROKEN. A TORQUE DRIVER TIP WAS STRIPPED. A REDUCER, CLIP AND SLEEVE HAD THREADS STRIPPED AND BOTH PIECES STUCK TOGETHER. NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. NEW DEVICES PROVIDED. THIS REPORT IS FOR ONE FLEX-CLIP FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171311 ↗
• MalfunctionNov 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING THE CLEANING PROCESS, IT WAS DISCOVERED THAT THE FUNCTIONING OF THE FLEX CLIP IN QUESTION WAS RESTRICTED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM CLIP-ON RED. DEV W/ DOVETAIL 5.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18119585 ↗
• 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 FLEX-CLIP. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899297 ↗
• MalfunctionFeb 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THE TIMING OF THE REPORTED EVENT WAS POSTOPERATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409228 ↗
• MalfunctionFeb 15, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS DISCOVERED PREOPERATIVELY THAT THE DEVICES WERE BROKEN. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM CLIP-ON RED. DEV W/ DOVETAIL 5.5MM. THIS IS REPORT 10 OF 13 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378167 ↗
• MalfunctionFeb 15, 2023Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS DISCOVERED PREOPERATIVELY THAT THE DEVICES WERE BROKEN. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM CLIP-ON RED. DEV W/ DOVETAIL 5.5MM. THIS IS REPORT 11 OF 13 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378166 ↗
• MalfunctionAug 23, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) 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)APPROXIMATOR FLEX-CLIP. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15278303 ↗
• MalfunctionJun 16, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A SCOLIOSIS CORRECTION SURGERY INVOLVING MULTIPLE VIPER CFX SCREWS (19) AND A SINGLE EXPEDUIM UNIPLANAR SCREW. THE PERSUASION AND DEROTATION MANEUVERS WERE PERFORMED ONTO THE CFX SCREWS WITH VIPER3D SYSTEMS AND ONTO THE EXPEDIUM UNIPLANAR SCREW WITH THE HELP OF A FLEX CLIP SYSTEM. WHEN THE AD-HOC DEROTATION WAS PERFORMED, THE SURGEON FINAL-LOCKED ALL SCREWS WITH THE APPROPRIATE TORQUE-LIMITING HANDLE. SINCE THIS CUSTOMER ALREADY ENCOUNTERED MULTIPLE ISSUES WHERE UNIPLANAR SCREWS WERE NOT STRONGLY HOLDING ON THE ROD, THUS ROTATING IN AN AXIAL PLANE AROUND THE ROD, THE CUSTOMER CHECKED THE ATTACHMENT STIFFNESS OF THE UNIPLANAR SCREW TO THE ROD (AFTER THE TORQUE LOCKING). THE CUSTOMER THEN PUSHED THE FLEX CLIP MEDICALLY AND THE UNIPLANAR SCREW CONSEQUENTLY TURNED IN AN AXIAL PLANE AS ALREADY ENCOUNTERED IN A COUPLE OF OTHER SURGERIES. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM CLIP-ON RED. DEV W/ DOVETAIL 5.5MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14714206 ↗
• 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 (1) APPROXIMATOR FLEX-CLIP. THIS IS REPORT 7 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14600641 ↗
• 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 FLEX-CLIP. THIS IS REPORT 8 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14600639 ↗
• 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 FLEX-CLIP. THIS IS REPORT 6 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14600635 ↗
• 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 FLEX-CLIP. THIS IS REPORT 2 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14600633 ↗
• MalfunctionMay 24, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6) THAT DURING THE CLEANING PROCESS-THE FLEX CLIP REDUKTION SLEEVEE AND EXP SLEEVE COULD NO LONGER BE REMOVED. THERE WAS NO PATIENT INVOLVEMENT AND NO SURGERY DELAY. THIS REPORT IS FOR ONE (1) . THIS IS REPORT 1 OF 2 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14488435 ↗
• MalfunctionMay 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE PLACING SET SCREWS, THE SURGEON USED THE EXPEDIUM 5.5 REDUCTION CLIP AND DRIVER TO DEPLOY A SET SCREW. ONCE REDUCED, THE SURGEON THREADED THE SET SCREW INTO THE TULIP HEAD OF THE SCREW AND MOVED TO RELEASE THE INSTRUMENT FROM THE SET SCREW. THE INNER DRIVE MECHANISM WOULD NOT DISENGAGE FROM THE SET SCREW WITHOUT SIGNIFICANT FORCE APPLIED TO THE DRIVER. DURING POST-OP INSPECTION IT WAS OBSERVED THAT SET SCREWS WERE NOT LOADING ONTO THE REDUCTION DRIVER CORRECTLY AND APPEARED TO LOAD ON AN ANGLE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH 3 MINUTES SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM CLIP-ON RED. DEV W/ DOVETAIL 5.5MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14396697 ↗