EXPEDIUM 299704135Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034467306), received between Sep 13, 2017 and Oct 29, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT WHEN ATTACHING TO THE SCREWDRIVER, THE INTERNAL SPRING TURNS EMPTY. THE RATCHET MECHANISM OF THE T-HANDLE IN THE VERSE SYSTEM HAS SIMPLY BROKEN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413402 ↗
• MalfunctionJan 9, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2023, DURING A LARGE REVISION CASE, THE SCREWS WERE VERY DIFFICULT TO GET OUT. MULTIPLE DRIVER HEADS BROKE AS WELL AS HANDLES. THERE WAS NO PATIENT CONSEQUENCE AND NO DELAY DUE TO THE EVENT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED THAT THE REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM T-HANDLE, RATCHETING. THIS IS REPORT 1 OF 10 FOR (B)(6). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS. THIS REPORT IS ALSO RELATED TO (B)(4), WHICH CAPTURES THE IMPLANT REMOVAL DUE TO INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476150 ↗
• MalfunctionJan 9, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING A LARGE REVISION CASE, THE SCREWS WERE VERY DIFFICULT TO GET OUT. MULTIPLE DRIVER HEADS BROKE AS WELL AS HANDLES. THERE WAS NO PATIENT CONSEQUENCE AND NO DELAY DUE TO THE EVENT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED THAT THE REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM T-HANDLE, RATCHETING. THIS IS REPORT 7 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS. THIS REPORT IS ALSO RELATED TO (B)(4). WHICH CAPTURES THE IMPLANT REMOVAL DUE TO INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476135 ↗
• MalfunctionNov 8, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED ON WEDNESDAY, OCTOBER 18TH, SETS WERE DROPPED OFF FOR CASES ON FRIDAY, OCTOBER 20TH. UPON RECEIPT OF THESE SETS, THERE WERE MULTIPLE INSTRUMENTS THAT WERE DUBBED UNFIT TO BE USED IN SURGERY (PART NUMBERS OF EACH INSTRUMENT HAVE BEEN INCLUDED). SPD RAN A BOROSCOPE DOWN EACH OF THE CANNULATED INSTRUMENTS (WHICH WE AS REPS DO NOT HAVE ACCESS TO AT ANY OF OUR ACCOUNTS TO CHECK THESE OURSELVES), AND FOUND MULTIPLE INSTRUMENTS THAT FELL OUTSIDE OF THEIR GUIDELINES FOR SAFE USE IN SURGERY. SUBSEQUENTLY, I HAD TO RUN TO MULTIPLE DIFFERENT HOSPITALS AROUND DENVER TO BE ABLE TO MAKE THESE SETS COMPLETE AND USABLE. THIS PUT ME OUTSIDE OF THE GUIDELINES PUT IN PLACE BY THE VA IN TERMS OF TIMELINESS ON DROPPING OFF THE TRAYS. EVENT OCCURRED DURING STERILE PROCESSING AND FIELD INSPECTION. THERE WERE PATIENT OUTCOMES OR CONSEQUENCES. ONE OF THE TWO CASES SCHEDULED HAD TO BE CANCELLED THIS REPORT IS FOR ONE (1) T-HANDLE, RATCHETING THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18096867 ↗
• MalfunctionApr 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THE PROCEDURE WAS A SPINAL FUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16786804 ↗
• MalfunctionApr 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR SPINAL FUSION. THE SCRUB NURSE PREOPERATIVELY TRIED TO CONNECT THE HEAD ADJUSTER TO A TEARDROP HANDLE (279702120), WHICH FAILED. ALSO, TRIED TO CONNECT THE HEAD ADJUSTER WITH ANOTHER COUNTERPART HANDLES SUCH AS 279702140, 286715300, AND 299704135, WHICH ALL WAS FAILED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT WITHOUT SURGICAL DELAY. THE PATIENT OUTCOME WAS STABLE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) T-HANDLE, RATCHETING. THIS REPORT IS 5 OF 5 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11756030 ↗
• InjuryAug 27, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN L4-L5 LAMINECTOMY, INSTRUMENTED FUSION WITH REDUCTION OF L4-5 ANTEROLISTHESIS, TRANSFORAMINAL INTERBODY PLACEMENT, USE OF ALLOGRAFT AND AUROGRAFT FUSION, INTRA-OPERATIVE NAVIGATION AND AIRO CT AND INSERTION OF LUMBAR DRAIN INDICATED BY NEUROGENIC CLAUDICATION, INTRACTABLE BACK AND LEG PAIN THAT HAS FAILED CONSERVATIVE CARE. INTRA-OPERATIVELY, DURING THE PLACEMENT OF THE L5 SCREW, THE DRIVER WITH THE SCREW DETACHED FROM THE HANDLE AND FELL INTO THE THECAL SAC RESULTING IN AN APPROXIMATELY 1CM DURAL TEAR EXTENDING JUST ROSTRAL TO THE SHOULDER OF THE L5 TRAVERSING NERVE ROOT DOWN TO JUST CAUDAL TO THE AXILLA OF THE TRAVERSING NERVE ROOT. THE TEAR WAS JUST LATERAL AND THE SCREW WAS IMMEDIATELY REMOVED AND THE CSF LEAK WAS TAMPONADED IMMEDIATELY WITH COTTONOIDS WITH COMPLETE CONTROL OF THE CSF LEAK. IT WAS CONCLUDED THAT THE DRIVER WITH THE SCREW HAD DETACHED FROM THE RATCHETING T-HANDLE. THE FINAL L5 SCREW WAS PLACED WITH A NEW HANDLE-DRIVER SYSTEM. BECAUSE OF THE MALFUNCTIONING EQUIPMENT AND SUBSEQUENT INJURY TO THE PATIENT'S SPINAL COLUMN RESULTING IN A TEAR, THE PATIENT WAS ON THE OPERATING TABLE FOR ABOUT 12 HOURS UNDER

  Patient problems: No Code Available

  MAUDE report 8937550 ↗
• MalfunctionSep 13, 2017Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  POSTERIOR LUMBAR FUSION L2-3. DURING FINAL TIGHTENING OF THE VERSE UNITIZED SET SCREWS, (B)(6) NOTICED THAT THE AUDIBLE CLICK OF THE 80IN-LB VERSE TORQUE HANDLE DIDN'T SOUND AS LOUD AND FELT WEAK. HE THEN REVISITED THE UNITIZED SET SCREWS WITH A SECOND VERSE TORQUE HANDLE FROM THE SECOND SURGEON SET AND NOTICED THAT IT HAD AN EXTRA HALF TURN BEFORE TORQUING OFF. NO TIME DELAY TO PROCEDURE. NO ADVERSE EVENT TO PATIENT. PHOTO AVAILABLE. PRODUCT DISCARDED HAS BEEN SELECTED FOR PRODUCT STATUS IN THIS INSTANCE AS THERE IS NO APPROPRIATE STATUS AVAILABLE TO REPRESENT THE FOLLOWING LOCAL PROCESS: INSTRUMENT WILL BE SENT TO LOCAL ENGINEERING FOR ASSESSMENT OF WEAR AND TEAR. IF "WEAR AND TEAR" IS ASSIGNED, A COPY OF THE LOCAL ASSESSMENT WILL BE PROVIDED TO THE MANUFACTURER FOR THEIR RECORD AND CASE CLOSURE. IN THE CASE WEAR AND TEAR CANNOT BE ASSIGNED BY THE ENGINEER, THE PRODUCT WILL BE RETURNED TO THE MANUFACTURER AS A PRODUCT COMPLAINT FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6861651 ↗