EXPEDIUM 179762300Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705034077420), received between Sep 15, 2017 and Sep 20, 2024 — classified as 14 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, AN EXPEDIUM SYSTEM IS USED WITH A 5.5MM BAR WITH A USS ILIOSACRAL SYSTEM THAT IS DESIGNED FOR 6.0MM BARS: LEFT AND RIGHT S2 CONNECTORS FOR 6MM BARS AND 5.5MM BAR. THE SCREW IS SENT MARKED, THE SCREW REMAINS WITH THE HEAD BLOCKED, THE SCREWDRIVER CANNOT BE CONNECTED TO EXTRACT THE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267795 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: NEUROCOMPRESSION, COMPLICATION TIME/INTERVENTION, REPEAT SURGERY. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM ROD 5.5 X 300MM. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: Nerve Damage

  MAUDE report 18462962 ↗
• InjuryJan 4, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE SURGERIES THROUGH 15-20 YEARS. THE SURGERY INVOLVED WITH THE IMPLANT IN QUESTION WAS PERFORMED ON (B)(6) 2020. BREAKAGE OF THE ROD OCCURRED POSTOPERATIVELY ON AN UNKNOWN DATE, BUT PATIENT DID NOT INITIALLY WISH TO HAVE REVISION SURGERY. REVISION WAS PERFORMED ON (B)(6) 2023 DUE TO THE PATIENT HAVING INCREASING BACK PAIN. NONUNION WAS ALSO NOTED ON AN UNKNOWN DATE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM ROD 5.5 X 300MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 18442815 ↗
• MalfunctionNov 22, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE RODS WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES (5) NUMBER OF DEVICES. THIS REPORT IS FOR (1) ROD, 300 MM. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12851546 ↗
• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE RODS WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES FIVE (5) NUMBER OF DEVICES. THIS REPORT IS FOR (1) ROD, 300 MM. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12848069 ↗
• MalfunctionNov 15, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE RODS WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT A THIRD PARTY SERVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM ROD 5.5 X 300MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12815128 ↗
• InjuryMar 17, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ROD WAS DISCOVERED AS BROKEN. REVISION THORACOLUMBAR FUSION WAS PERFORMED FOR BROKEN ROD AT L2 (R). THE PATIENT REQUIRED REVISION SURGERY FOR A BROKEN ROD AT T2 (L). THE SURGEON STATED THAT THE PATIENT HAD A NON-UNION AND THAT THIS WOULD HAVE CAUSED THE ROD TO BREAK. HE REPLACED THE RODS ON BOTH SIDES AND SEVERAL SCREWS ABOVE AND BELOW THE BROKEN ROD ON THE LEFT. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY UNKNOWN); UNKNOWN SETSCREWS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 9842770 ↗
• InjuryJul 24, 2019Break; Break

  EVENT: THE EXPEDIUM TITANIUM BARS AND THE SFX BROKE INSIDE THE PATIENT AFTER A FALL, WHICH LED TO THE SURGICAL NECESSITY OF THE SAME. MEDICAL REPORT: MATERIAL TAKEN FROM THE ATN PATIENT, ON (B)(6) 2019, IN THIS HOSPITAL BY DR. (B)(6). MATERIAL WAS BROKEN, ACCORDING TO X-RAY ATTACHED, AFTER THE PATIENT SUFFERED A FALL. I LEAVE THE MATERIAL IN THE POSSESSION OF THE NURSES (B)(6) FOR LATER WITHDRAWAL FROM THE HOSPITAL FOR OUR LOGISTICS. SALES REP COMMUNICATED VIA (B)(6) THAT THE OPERATING COMPANY OF THE MATERIALS IS DEPUY SPINE, OF REFERENCES: TITANIUM ROD 1797-62-300, SFX 1894-014-06. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Code Available

  MAUDE report 8822019 ↗
• InjuryMar 7, 2019Break; Break

  THE FOLLOWING WAS REPORTED: REVISION T4-PELVIS & BROKEN PEDICLE SCREWS: DR (B)(6), (B)(6) HOSPITAL, (B)(6) 2019. PT HAD A POSTERIOR SPINAL FUSION FOR SPINAL DEFORMITY, T4-PELVIS ((B)(6) 2016). IT WAS QUITE A SIGNIFICANT DEFORMITY. IT WAS NOTED THAT THE RODS BROKE AT L1 (2018) WHERE THERE IS A NON-UNION. THIS IS STAGE 1 OF 2. THE RODS WERE REMOVED ON BOTH SIDES, BROKEN SCREWS REMOVED, NEW SCREWS IMPLANTED AND THEN NEW COCR RODS. TWO NEW SFX CROSS CONNECTORS WERE ALSO USED. IMPACTED PRODUCT: UNKNOWN SPD= 5.5MM ROD, TI, CODE: 2797.62.300, NOT AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 8400667 ↗
• InjuryOct 29, 2018Break; Break

  IT WAS REPORTED A REVISION FROM T10-PELVIS FOR BILATERAL BROKEN RODS DUE TO NON-UNION AT L5/S1. THE ROD HAD BROKEN ABOVE S1 ON THE RIGHT AND BELOW S1 ON THE LEFT. SURGEON REMOVED THE RODS ON BOTH "SIDE", REPLACED THE SCREWS AT L)4, R) AND THEN BOTH SIDES AT L5 AND S1 AND THE ILIAC SCREW, R). SURGEON HAS A ROUTINE OF REPLACING THE SCREWS THAT ARE NEAREST THE BREAK TO THE ROD. THERE WAS NO FAULT OF THE SCREWS. REVISION T10-PELVIS. PRIMARY IMPLANT DATE: (B)(6) 2014.

  Patient problems: No Code Available

  MAUDE report 8016348 ↗
• MalfunctionApr 18, 2018Break; Break

  COMPLAINT DESCRIPTION: THE EXPERIENCED SENIOR SURGEON HAVE HIS 3. RODBREAKE - FURTHER INFO WILL COME.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7439354 ↗
• InjuryDec 14, 2017Break; Break

  IT WAS REPORTED ON (B)(6), 2017, SURGEON PERFORMED A CASE TO TREAT A NON UNION AT L4/5. THE PATIENT HAD PREVIOUSLY UNDERGONE A T10-ILIUM FUSION. WHEN SPEAKING WITH SURGEON, HE INFORMED ME PRIOR TO THE CASE THAT THERE WAS A NON UNION AT L4/5 WHICH CAUSED THE RODS TO BREAK. HE EXPOSED THE FRACTURED RODS AND USED LATERAL CONNECTORS TO PLACE A SECOND STABILIZING ROD ON EACH SIDE. IN TOTAL, 6 LATERAL CONNECTORS WERE USED (3 ON EACH SIDE). HE ALSO USED AND END TO END CONNECTOR TO STABILIZE THE ROD AT THE FRACTURE SITE. THE CASE WAS COMPLETED SUCCESSFULLY, AND SURGEON SEEMED PLEASED WITH THE RESULT.

  Patient problems: Spinal Column Injury

  MAUDE report 7118282 ↗
• InjuryDec 14, 2017Break; Break

  IT WAS REPORTED ON (B)(6), 2017, SURGEON PERFORMED A CASE TO TREAT A NON UNION AT L4/5. THE PATIENT HAD PREVIOUSLY UNDERGONE A T10-ILIUM FUSION. WHEN SPEAKING WITH SURGEON, HE INFORMED ME PRIOR TO THE CASE THAT THERE WAS A NON UNION AT L4/5 WHICH CAUSED THE RODS TO BREAK. HE EXPOSED THE FRACTURED RODS AND USED LATERAL CONNECTORS TO PLACE A SECOND STABILIZING ROD ON EACH SIDE. IN TOTAL, 6 LATERAL CONNECTORS WERE USED (3 ON EACH SIDE). HE ALSO USED AND END TO END CONNECTOR TO STABILIZE THE ROD AT THE FRACTURE SITE. THE CASE WAS COMPLETED SUCCESSFULLY, AND SURGEON SEEMED PLEASED WITH THE RESULT.

  Patient problems: Spinal Column Injury

  MAUDE report 7118209 ↗
• InjuryDec 14, 2017Break; Break

  IT WAS REPORTED PATIENT HAD TWO BROKEN RODS THAT WERE REMOVED AND REPLACED.

  Patient problems: Spinal Column Injury

  MAUDE report 7116998 ↗
• InjuryDec 14, 2017Break; Break

  IT WAS REPORTED PATIENT HAD TWO BROKEN RODS THAT WERE REMOVED AND REPLACED.

  Patient problems: Spinal Column Injury

  MAUDE report 7116909 ↗
• InjuryNov 20, 2017Break; Break

  REVISION T3-PELVIS. THE PATIENT HAD A PREVIOUS REVISION FOR BROKEN RODS IN (B)(6) 2016. THE PATIENT HAS A HISTORY OF RHEUMATOID ARTHRITIS. REVISION (B)(6) 2017 PATIENT HAS BROKEN RODS AND A NON UNION AT T9. THE PLANNED OPERATION WAS AN ANTERIOR APPROACH TO ADDRESS THE NON UNION AND THEN TURN THE PATIENT OVER TO ATTEND TO THE BROKEN RODS. ANTERIOR OPERATION COMPLETED AND THEN THE POSTERIOR OPERATION. THERE IS A VERY SOLID FUSION FROM THE PREVIOUS SURGERY EXCEPT AT THE NON-UNION SITE. THE EXISTING RODS WERE CUT AND THE SURGEON USED CONNECTORS TO ADD NEW RODS AND MAKE A SUPPORTIVE STRUT CONSTRUCT. XRAY AVAILABLE.

  Patient problems: Failure of Implant; Injury

  MAUDE report 7044900 ↗
• InjuryNov 20, 2017Break; Break

  REVISION T3-PELVIS. THE PATIENT HAD A PREVIOUS REVISION FOR BROKEN RODS IN (B)(6) 2016. THE PATIENT HAS A HISTORY OF RHEUMATOID ARTHRITIS. REVISION (B)(6) 2017 PATIENT HAS BROKEN RODS AND A NON UNION AT T9. THE PLANNED OPERATION WAS AN ANTERIOR APPROACH TO ADDRESS THE NON UNION AND THEN TURN THE PATIENT OVER TO ATTEND TO THE BROKEN RODS. ANTERIOR OPERATION COMPLETED AND THEN THE POSTERIOR OPERATION. THERE IS A VERY SOLID FUSION FROM THE PREVIOUS SURGERY EXCEPT AT THE NON-UNION SITE. THE EXISTING RODS WERE CUT AND THE SURGEON USED CONNECTORS TO ADD NEW RODS AND MAKE A SUPPORTIVE STRUT CONSTRUCT. XRAY AVAILABLE.

  Patient problems: Failure of Implant; Injury

  MAUDE report 7044881 ↗
• InjuryNov 8, 2017Break; Break

  NON UNION AT L3/BROKEN SCREW - ANTERIOR SCOLIOSIS PSF. CONGENITAL SCOLIOSIS. REVISION OF THE ANTERIOR FUSION (T11-L3) OF AN ANTERIOR/POSTERIOR SCOLIOSIS FUSION. ORIGINAL SURGERY PERFORMED IN 2007. PATIENT PRESENTED WITH A NON UNION AT L3 AND A BROKEN SCREW AT L3. THE SURGEON IS NOT SURE WHICH OCCURRED 1ST. THE BROKEN HEAD OF THE SCREW, MONOAXIAL SCREW AT L2, SINGLE STAPLE (X 1), SET SCREWS (X5) AND SINGLE ROD WERE REMOVED. THE SURGEON WAS UNABLE TO REMOVE THE SHAFT OF THE SCREW AT L3 (PHOTO ATTACHED). SCREW REMOVED AND REPLACED AT L2 AND THEN PLACED ANOTHER SCREW, BESIDE L2 AND L3. A ROD WAS THEN PLACED IN T11-L3 AND IN THE NEW SCREWS, L2 AND L3. PLEASE SEE ATTACHED PHOTOS OF THE FINAL X-RAY. HE ALSO PLACED A MESH CAGE IN THE DISC SPACE BETWEEN L2 AND L3 TO ASSIST WITH SCOLIOSIS. PHOTOS OF X-RAYS, EXPLANTED IMPLANTS AND POST OP PHOTO OF THE X-RAY

  Patient problems: Failure of Implant; Injury; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7009012 ↗
• InjurySep 15, 2017Break; Break

  REVISION FUSION. PRIMARY IMPLANT DATE: (B)(6) 2010. REVISION FOR OR BROKEN SCREW L5/S1 NON UNION, RODS BROKEN AT S1 -ILIAC. AE TO PATIENT; NON UNION AND PAIN. THIS CASE IS NOT BEING REPORTED BY THE CUSTOMER, BUT JJM EMPLOYEE. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AS PART OF THIS REPORT, NO FURTHER INFORMATION WILL BE FORTHCOMING.

  Patient problems: Failure of Implant; Injury

  MAUDE report 6870442 ↗