EXPEDIUM 279712580Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 10705034199009), received between Aug 25, 2017 and Mar 25, 2026 — classified as 1 injury, 68 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (41 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 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Break

  IT WAS REPORTED THAT THE DISTAL TIP OF THE INSTRUMENT HAS DETACHED, RENDERING THE INSTRUMENT UNUSABLE. THIS OCCURRED DURING SURGERY, BUT NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690803 ↗
• MalfunctionJun 10, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  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 22177901 ↗
• MalfunctionJun 10, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  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 22177877 ↗
• MalfunctionSep 20, 2024Material Deformation; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20269157 ↗
• MalfunctionSep 20, 2024Material Deformation; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20269156 ↗
• MalfunctionSep 20, 2024Material Deformation; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20269151 ↗
• MalfunctionSep 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  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 20191220 ↗
• 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 SLEEVE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171451 ↗
• MalfunctionJul 2, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE LOWER DISTAL PART WILL NOT ROTATE SO IT CANNOT BE REDUCED IN THE FLEXCLIP AS IT CANNOT BE ROTATED. SEEMS LIKE IT IS STUCK. SURGEON HAD TO FORCE IT OF THE SCREW SINCE IT WOULD NOT SCREW OUT OF THE FLEXCLIP AND DETACHED FROM THE PT. THERE WAS A THIRTY (30) MINUTES OF SURGICAL DELAY DUE TO REPORTED EVENT. THIS REPORT IS FOR ONE (1) APPROXIMATOR FC SLEEVE THIS IS REPORT 1 OF 1 FOR COMPLAINT(B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19661124 ↗
• 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) APPROXIMATOR FC SLEEVE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353167 ↗
• MalfunctionMay 1, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A FINAL TIGHTENER. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220414 ↗
• MalfunctionApr 4, 2024Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE TIP OF INSTRUMENT HAS LOOSENED FROM REST OF INSTRUMENT INTRAOPERATIVELY. THERE WAS NO PATIENT CONSEQUENCE. SURGERY PERFORMED AS PLANNED. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) APPROXIMATOR FC SLEEVE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19046952 ↗
• MalfunctionApr 4, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 THE VIPER SC SCREWDRIVER AND EXPEDIUM DRIVERS ARE DEFECTIVE AND CANNOT BE USED. IT HAS NO GRIP ON THE TIP AND HAS ROUNDED TIP. THE PATIENT WAS INVOLVED, BUT DUE TO AVAILABILITY OF SPARE DEVICES ON THE TRAY THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM CLIP-ON RED.DRIVER W/DOVETAIL 5.5MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19041662 ↗
• MalfunctionDec 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, A SINGLE INNIE SET SCREW BECAME STUCK INSIDE OF THE REDUCTION SLEEVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER REDUCTION SLEEVE FROM THE SET. THERE WAS NO ADVERSE PATIENT IMPACT OR SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM CLIP-ON RED.DRIVER W/DOVETAIL 5.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18404099 ↗
• MalfunctionDec 8, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, WHEN A CLIP -ON DEVICE WAS USED, THE TIP OF THE INSERTER CAME OFF WHEN THE INSERTER WAS REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THE PATIENT STATUS WAS REPORTED TO BE STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM CLIP-ON RED.DRIVER W/DOVETAIL 5.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18291773 ↗
• MalfunctionOct 16, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, DURING POSTERIOR SPINAL FUSION SURGERY, THE SET SCREW BECAME LODGED INSIDE OF THE APPROXIMATOR SLEEVE AND IT WAS UNABLE TO BE REMOVED. 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 CLIP-ON RED DRIVER W/DOVETAIL 5.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17943647 ↗
• MalfunctionOct 16, 2023Break; Break

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 26-SEPTEMBER-2023, THE REDUCTION SLEEVE IN QUESTION WAS FOUND TO HAVE LOST ITS DISTAL END PIECE. THIS RENDERS THE SLEEVE UNABLE TO BE USED. THE INSTRUMENT WAS NOT USED DURING SURGERY, THERE WAS NO REPORTED PROCEDURE OR PATIENT INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM CLIP-ON RED.DRIVER W/DOVETAIL 5.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940681 ↗
• MalfunctionAug 30, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN SURGERY WAS PERFORMED FOR LUMBAR DEGENERATIVE DISEASE ON (B)(6), 2023. THE SURGEON PUT A SET SCREW ON THE INSERTER AND PUT IT THROUGH THE PRODUCT, AND THE SET SCREW CAME OFF INSIDE THE PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM CLIP-ON RED. DRIVER W/DOVETAIL 5.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650043 ↗
• MalfunctionAug 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 AN UNKNOWN SURGERY WAS PERFORMED. A SET SCREW GOT INSIDE THE APPROXIMATOR FC SLEEVE AND COULD NOT BE REMOVED. SINCE THIS EVENT OCCURRED BEFORE THE APPROXIMATOR FC SLEEVE WAS USED, ANOTHER APPROXIMATOR FC SLEEVE WAS USED IN THE SURGERY. THEREFORE, THIS EVENT DID NOT IMPACT THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM CLIP-ON RED.DRIVER W/DOVETAIL 5.5MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT(B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17503195 ↗
• MalfunctionJul 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE SPRING DISENGAGED FROM THE HOLDER. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) APPROXIMATOR FC SLEEVE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17395781 ↗
• MalfunctionJul 25, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT THE CUSTOMER IS COMPLAINING THE INSTRUMENT AS THE SOCKET FOR PICKING UP THE INNIE DETACHES FROM THE INSTRUMENT. NO ADVERSE PATIENT CONSEQUENCES, NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) APPROXIMATOR FC SLEEVE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17391461 ↗
• MalfunctionJul 20, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGERY PERFORMED ON (B)(6) 2023, WHEN THE SURGEON USED THE APPROXIMATOR FC SLEEVE TO SET A ROD TO A SAI SCREW, THE SET SCREW STUCK INSIDE THE APPROXIMATOR FC SLEEVE AND COULD NOT BE REMOVED. THE SURGEON DIDN'T USE THE APPROXIMATOR FC SLEEVE IN ANY PARTICULAR UNUSUAL WAY. THE SURGEON SAID THAT THE APPROXIMATOR FC SLEEVE COULD HAVE DETERIORATED OVER TIME. THE SURGERY AND PATIENT WERE NOT AFFECTED BY THIS EVENT BECAUSE THERE WERE SPARE PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE APPROXIMATOR FC SLEEVE IS A LONG-TERM CONSIGNMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) APPROXIMATOR FC SLEEVE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17364792 ↗
• 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 APRIL 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 SLEEVE THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899302 ↗
• MalfunctionApr 13, 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 CLIP-ON RED. DRIVER W/DOVETAIL 5.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16734440 ↗
• 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 16409272 ↗