EXPEDIUM 179712735Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034067889), received between May 31, 2018 and Sep 15, 2022 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2022Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED TO REMOVE OSTEOSYNTHESIS MATERIAL OF THE SPINE (EXPEDIUM 5.5 SYSTEM) BECAUSE ONE OF THE SCREWS IMPLANTED IN THE PATIENT BROKE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 7 X 35MM. THIS IS REPORT 2 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15428112 ↗
• InjurySep 13, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY TO REMOVE OSTEOSYNTHESIS MATERIAL OF THE SPINE (EXPEDIUM 5.5 SYSTEM) BECAUSE ONE OF THE SCREWS IMPLANTED IN THE PATIENT BROKE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 7 X 35MM. THIS IS REPORT 1 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15414071 ↗
• InjuryFeb 24, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SPINAL FUSION SURGERY ON (B)(6) 2021 DUE TO BROKEN SCREWS AT S1. THERE WERE NO OBVIOUS FRAGMENTS AND TWO (2) SI POLYAXIAL SCREWS WERE REMOVED. THE ORIGINAL SURGERY FOR HIGH GRADE SPONDYLOLISTHESIS TOOK PLACE ON (B)(6) 2017. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2); UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 4); UNKNOWN SETSCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 6). THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 7 X 35MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11376827 ↗
• InjuryFeb 24, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SPINAL FUSION SURGERY ON (B)(6) 2021 DUE TO BROKEN SCREWS AT S1. THERE WERE NO OBVIOUS FRAGMENTS AND TWO (2) SI POLYAXIAL SCREWS WERE REMOVED. THE ORIGINAL SURGERY FOR HIGH GRADE SPONDYLOLISTHESIS TOOK PLACE ON (B)(6) 2017. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2); UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 4); UNKNOWN SETSCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 6). THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 7 X 35MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11376818 ↗
• InjuryDec 3, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS INITIALLY IMPLANTED WITH HARDWARE ON (B)(6) 2019. POST-SURGERY THE PATIENT HAD A LUMBAR PAIN. THE PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2020, TO PLACE AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) ANTERIOR BOX. DURING THE SURGERY, SURGEON NOTICED THAT ONE OF THE SCREWS WAS BROKEN, WHICH WAS REMOVED, AND REPLACED WITHOUT ANY DIFFICULTIES, AND THEN SURGEON CONTINUED WITH THE PROCEDURE, THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN SET SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 7 X 35MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 10942686 ↗
• InjuryNov 25, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT ORIGINAL L5/S1 FUSION SURGERY ON (B)(6) 2017. ON AN UNKNOWN POSTOPERATIVE DATE S1 SCREWS FRACTURED AND L5 SCREWS LOOSENED, WHICH RESULTED IN NEED FOR REVISION PROCEDURE ON (B)(6) 2019 TO REMOVE BROKEN SCREWS AND REVISE BOTH L5 AND S1 SCREWS DUE TO PAIN AND DYSFUNCTION. THIS WAS A PLANNED REVISION SURGERY. THERE WAS SURGICAL DELAY OF APPROXIMATELY FIFTEEN (15) MINUTES TO REMOVE BROKEN SCREWS. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 9371245 ↗
• InjuryMar 12, 2019Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  EXPEDIUM SCREW HEAD BROKE DURING PROCEDURE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? - YES, IF YES, NUMBER OF MINUTES: - 5, ACTION TAKEN WHEN EVENT OCCURRED? - SCREW REMOVED AND REPLACED , WAS PROCEDURE SUCCESSFULLY COMPLETED? - YES, WERE FRAGMENTS GENERATED? - YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? - YES, PATIENT STATUS/ OUTCOME / CONSEQUENCES - NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: - UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY - NO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8413092 ↗
• InjuryNov 14, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  THE L5 LUMBAR SPONDYLOLISTHESIS RECONSTRUCTION SURGERY WAS PERFORMED WITH EXPEDIUM SI AND HOOK SYSTEM ON (B)(6) 2018. IT WAS REPORTED THAT THE SURGEON COULD NOT APPLY THE TORQUE FOR FINAL TIGHTENING THE SET SCREWS. THE SURGEON CONFIRMED THERE WAS NO CROSS-THREADED, SO THAT THE SURGEON ATTEMPTED TO TIGHTEN COUPLE OF TIME, BUT THE SURGEON COULD NOT TIGHTEN THE SET SCREWS. THEN, THE SURGERY WAS COMPLETED BY REPLACING THE SCREW WHICH REMOVED FROM THE PATIENT¿S LUMBAR. AFTER THE REMOVING THE SCREWS, THE SURGEON RECOGNIZED THERE WAS METAL LIKE FRAGMENT AROUND THE SCREW. THERE WAS 45MIN SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8071201 ↗
• InjuryJun 1, 2018Break; Break

  PT SCHEDULED FOR REVISION L5-S1 FUSION. PT PRESENTED WITH BILATERAL S1 BROKEN SCREWS (7.0 X 35MM EXPEDIUM POLYS). EXISTING HARDWARE AT S1 WAS REMOVED USING TREPHINES AND SCREW EXTRACTORS. S1 SCREWS WERE REPLACED WITH 8.0 X 35MM POLYS. THE LEFT S1 SCREW WAS INSERTED UNTIL THE DISTAL TIP REACHED THE CONTRALATERAL CORTEX OF THE SACRUM. SURGEON FELT SCREW WAS TOO PROUD AND ATTEMPTED TO ADVANCE THE SCREW SHEARING OF THE TIP OF THE EXPEDIUM QUICK CONNECT POLY DRIVER INTO THE SHANK OF THE SCREW. SURGEON TRIED TO ADVANCE BY LOCKING ROD INTO SCREW AND TURNING WITH COUNTER TORQUE WITH NO RESULTS. SURGEON REMOVED SCREW HEAD WITH DIAMOND BUR AND ATTEMPTED TO REMOVE SHANK WITH SCREW EXTRACTOR, NO RESULTS. SURGEONS ABANDONED THE SCREW REMOVAL AND COMPLETED THE CONSTRUCT FROM L4-ILEUM. NO FURTHER ISSUES. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Spinal Column Injury

  MAUDE report 7561980 ↗
• InjuryMay 31, 2018Break; Break

  PT SCHEDULED FOR REVISION L5-S1 FUSION. PT PRESENTED WITH BILATERAL S1 BROKEN SCREWS (7.0 X 35MM EXPEDIUM POLYS). EXISTING HARDWARE AT S1 WAS REMOVED USING TREPHINES AND SCREW EXTRACTORS. S1 SCREWS WERE REPLACED WITH 8.0 X 35MM POLYS. THE LEFT S1 SCREW WAS INSERTED UNTIL THE DISTAL TIP REACHED THE CONTRALATERAL CORTEX OF THE SACRUM. SURGEON FELT SCREW WAS TOO PROUD AND ATTEMPTED TO ADVANCE THE SCREW SHEARING OF THE TIP OF THE EXPEDIUM QUICK CONNECT POLY DRIVER INTO THE SHANK OF THE SCREW. SURGEON TRIED TO ADVANCE BY LOCKING ROD INTO SCREW AND TURNING WITH COUNTERTORQUE WITH NO RESULTS. SURGEON REMOVED SCREW HEAD WITH DIAMOND BUR AND ATTEMPTED TO REMOVE SHANK WITH SCREW EXTRACTOR, NO RESULTS. SURGEONS ABANDONED THE SCREW REMOVAL AND COMPLETED THE CONSTRUCT FROM L4-ILEUM. NO FURTHER ISSUES. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Spinal Column Injury

  MAUDE report 7558200 ↗