EXPEDIUM 179797040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034082929), received between Nov 8, 2017 and Aug 25, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Torn Material” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, THE OPEN POLYAXIAL LATERAL CONNECTOR WAS BROKEN DURING THE CAP FINALIZE STEP. THE CONNECTOR HEAD AND ROD WERE DISASSEMBLED AT THE TIME. A NEW ONE WAS USED INSTEAD. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN (10) MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN EXPEDIUM 5.5 OPEN CONNECTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10447742 ↗
• MalfunctionNov 8, 2017Torn Material; Torn Material

  IN (B)(6) 2017, THE PATIENT HAS HAD A MINIMALLY INVASIVE SURGERY WITH EXPEDIUM VIPER. THE CONSTRUCT INCLUDED 18 SCREWS INSERTED FROM T11 TO PELVIS, 2 OPEN ILIAC CONNECTORS OF 40MM, 1 COCRO ROD OF 480MM CUT BY HALF FOR EACH OF THE SIDES AND 20 INNIES. A REVISION SURGERY HAS BEEN PERFORMED TODAY BECAUSE THE ROD ON THE LEFT HAND SIDE OF THE PATIENT HAD SLIDED. ONE SCREW HAD NO ROD IN ITS HEAD ANYMORE. THE LORDOSIS WAS NOT IDENTICAL ANYMORE ON THE TWO SIDES EITHER. THE PATIENT ALSO SEEMINGLY REPORTED DISCOMFORT. DURING THE REVISION SURGERY, ALL SET SCREWS HAVE BEEN REMOVED. THE SURGEONS HAVE REPORTED THAT ON THE LEFT HAND SIDE, THE SET SCREWS WERE LOOSE FROM L3 TO PELVIS AND ON THE RIGHT HAND SIDE, THEY WERE LOOSE FROM L2 TO PELVIS. A VERY TINY PORTION OF ONE SET SCREW THREAD WAS FOUND BROKEN WHILE REMOVING THE SET SCREWS. IN ADDITION, SURGEONS COULDN'T REPLACE THE INNIE OF THE ILIAC CONNECTOR ON THE LEFT HAND SIDE, AS IT WAS NOT HOLDING PROPERLY ANYMORE. THEY FOUND OUT THAT THE HEAD OF THE CONNECTOR HAD WIDENED AND DUE TO THE DEFORMATION, THE SET SCREW WAS NOT SITTING IN PROPERLY ANYMORE. THEY HAVE THEREFORE DECIDED TO REPLACE BOTH ILIAC CONNECTORS TOO. FINALLY, THEY'VE REPLACED THE 4

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7009070 ↗
• MalfunctionNov 8, 2017Torn Material; Torn Material

  IN (B)(6) 2017, THE PATIENT HAS HAD A MINIMALLY INVASIVE SURGERY WITH EXPEDIUM VIPER. THE CONSTRUCT INCLUDED 18 SCREWS INSERTED FROM T11 TO PELVIS, 2 OPEN ILIAC CONNECTORS OF 40MM, 1 COCRO ROD OF 480MM CUT BY HALF FOR EACH OF THE SIDES AND 20 INNIES. A REVISION SURGERY HAS BEEN PERFORMED TODAY BECAUSE THE ROD ON THE LEFT HAND SIDE OF THE PATIENT HAD SLIDED. ONE SCREW HAD NO ROD IN ITS HEAD ANYMORE. THE LORDOSIS WAS NOT IDENTICAL ANYMORE ON THE TWO SIDES EITHER. THE PATIENT ALSO SEEMINGLY REPORTED DISCOMFORT. DURING THE REVISION SURGERY, ALL SET SCREWS HAVE BEEN REMOVED. THE SURGEONS HAVE REPORTED THAT ON THE LEFT HAND SIDE, THE SET SCREWS WERE LOOSE FROM L3 TO PELVIS AND ON THE RIGHT HAND SIDE, THEY WERE LOOSE FROM L2 TO PELVIS. A VERY TINY PORTION OF ONE SET SCREW THREAD WAS FOUND BROKEN WHILE REMOVING THE SET SCREWS. IN ADDITION, SURGEONS COULDN'T REPLACE THE INNIE OF THE ILIAC CONNECTOR ON THE LEFT HAND SIDE, AS IT WAS NOT HOLDING PROPERLY ANYMORE. THEY FOUND OUT THAT THE HEAD OF THE CONNECTOR HAD WIDENED AND DUE TO THE DEFORMATION, THE SET SCREW WAS NOT SITTING IN PROPERLY ANYMORE. THEY HAVE THEREFORE DECIDED TO REPLACE BOTH ILIAC CONNECTORS TOO. FINALLY, THEY'VE REPLACED THE 4

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7009056 ↗