EXPEDIUM 196791455Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034295312), received between Apr 3, 2018 and Mar 7, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 8400607 ↗
• InjuryJun 5, 2018Break; Break

  REV T3-PELVIS, BROKEN RODS AT L5/S1; (B)(6) 2018. PT IN FOR SURGERY FOR BROKEN RODS AT L5/S1 ON BOTH SIDES. EXISTING CONSTRUCT - T3-PELVIS ((B)(6) 2015). SURGEON STATED THAT THERE WAS NO OBVIOUS NON UNION. REPLACED SCREWS AND RODS, AT L4-PELVIS. ALSO NOTED THAT WHEN HE WENT TO REMOVE THE ILIAC SCREW ON THE L) SIDE, THE SCREW HEAD BROKE OFF FROM THE SHAFT. THE SURGEON LEFT THIS IN THE PATIENT AND PLACED ANOTHER SCREW IN THE PELVIS. THE RODS WERE REMOVED AND REPLACED AND JOINED TO THE REMAINING CONSTRUCT WITH AXIAL CONNECTORS.

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7568696 ↗
• InjuryJun 5, 2018Break; Break

  REV T3-PELVIS, BROKEN RODS AT L5/S1; (B)(6) HOSPITAL (B)(6) 2018. PT IN FOR SURGERY FOR BROKEN RODS AT L5/S1 ON BOTH SIDES. EXISTING CONSTRUCT - T3-PELVIS ((B)(6) 2015). SURGEON STATED THAT THERE WAS NO OBVIOUS NON UNION. REPLACED SCREWS AND RODS, AT L4-PELVIS. ALSO NOTED THAT WHEN HE WENT TO REMOVE THE ILIAC SCREW ON THE L) SIDE, THE SCREW HEAD BROKE OFF FROM THE SHAFT. THE SURGEON LEFT THIS IN THE PATIENT AND PLACED ANOTHER SCREW IN THE PELVIS. THE RODS WERE REMOVED AND REPLACED AND JOINED TO THE REMAINING CONSTRUCT WITH AXIAL CONNECTORS.

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7568639 ↗
• InjuryApr 3, 2018Break; Break

  SURGEON REQUESTED HARDWARE REMOVAL INSTRUMENTS FOR (B)(6) 18 REVISION OF A (B)(6) 2017 INSTRUMENTED CASE. (B)(6) 2017 CASE WAS AN EXTENSION TO AND KATI GET REVISION,HARDWARE FROM T3-PELVIS. L2 SCREWS WERE SKIPPED, HARDWARE 455MM PRE BENT COCR ROD BROKE ON PATIENTS RIGHT SIDE AT L2 ALONG WITH THE EXPEDIUM 5.5 SFX. SURGEON REMOVED VERSE SCREWS L3-SACRO ILIAC FULLY THREADED SAI. SURGEON STATED SET SCREWS WERE LOOSE IN REMOVAL. SURGEON ALSO STATED THAT THE FORMABLE VIVIGEN WAS COMING OUT LIKE IT WENT IN PATIENT CONSEQUENCE? UNKNOWN. ACTION TAKEN FOR PROCEDURE:SURGEON REVISED CONSTRUCT REMOVING L3-PELVIS DEPUY REVISED WITH INVASIVE RELIGN SCREWS AND END TO END CONNECTORS. 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 7393455 ↗