EXPEDIUM 179712550Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034067575), received between Aug 29, 2022 and Oct 21, 2022 — classified as 3 injuries.

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

• InjuryOct 21, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CYPRUS AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT WAS OPERATED 2 YEARS AGO WITH LUMBAR SPINE FUSION (USING 7 PEDICLE SCREWS). PATIENT CAME BACK TO THE NEUROSURGEON A MONTH AGO WITH A LOT OF PAIN. X-RAY TAKEN ON AN UNKNOWN DATE REVEALED 3 BROKEN SCREWS. SURGEON PERFORMED REVISION SURGERY ON (B)(6) 2022 AND REPLACED 3 BROKEN SCREWS WITH A BIGGER DIAMETER OF 6.0 MM SCREW. ALSO HE CHANGED ANOTHER ONE SCREW OF 5.0 MM WITH A 6.0 MM SCREW. FINALLY HE DECIDED TO ADD 5 MORE SCREWS 4 AT THE THORACIC LEVELS AND ONE SCREW AT THE SACRUM SO AS TO EXPAND THE 2 LEVEL FUSION TO AN ADULT SCOLIOSIS OPERATION. THERE WAS A SURGICAL DELAY OF UNSPECIFIED AMOUNT AS SURGEON HAD TO USE DRILL AND KERISSON TOOL TO REMOVE BROKEN SCREWS. THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 5 X 50MM THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 15653852 ↗
• InjuryOct 21, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CYPRUS AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT WAS OPERATED 2 YEARS AGO WITH LUMBAR SPINE FUSION (USING 7 PEDICLE SCREWS). PATIENT CAME BACK TO THE NEUROSURGEON A MONTH AGO WITH A LOT OF PAIN. X-RAY TAKEN ON AN UNKNOWN DATE REVEALED 3 BROKEN SCREWS. SURGEON PERFORMED REVISION SURGERY ON (B)(6) 2022 AND REPLACED 3 BROKEN SCREWS WITH A BIGGER DIAMETER OF 6.0 MM SCREW. ALSO HE CHANGED ANOTHER ONE SCREW OF 5.0 MM WITH A 6.0 MM SCREW. FINALLY HE DECIDED TO ADD 5 MORE SCREWS 4 AT THE THORACIC LEVELS AND ONE SCREW AT THE SACRUM SO AS TO EXPAND THE 2 LEVEL FUSION TO AN ADULT SCOLIOSIS OPERATION. THERE WAS A SURGICAL DELAY OF UNSPECIFIED AMOUNT AS SURGEON HAD TO USE DRILL AND KERISSON TOOL TO REMOVE BROKEN SCREWS. THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 5 X 50MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 15653845 ↗
• InjuryAug 29, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM CYPRUS REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED ON A PATIENT THAT HAD UNDERWENT LUMBAR SPINE FUSION (USING 8 PEDICLE SCREWS) 6 MONTHS AGO. ONE MONTH AGO, THE PATIENT HAD AN ACCIDENT AND SLIPPED AND FELL TO THE FLOOR. AFTER THAT, THE PATIENT WAS IN TERRIBLE PAIN AND HAD AN X-RAY AND A CT SCAN. THE PAIN DID NOT GO AWAY SO THE DOCTOR DECIDED TO OPERATE ON THE PATIENT AGAIN. DURING THE REVISION PROCEDURE, THE SURGEON COULD SEE THAT THE SCREWS OF THE CROSSLINK PLATE WERE ALMOST UNLOCKED AND ONE PEDICLE SCREW WAS FALLING OUT, CREATING A BLACK COLOR IN THE FIELD AROUND IT. WHEN THE SURGEON REMOVED THE CROSSLINK PLATE, THE ROD WAS CUT OUT AS WELL. AFTER THE ROD REMOVAL, IT WAS NOTICED THAT A SCREW WAS FALLING OUT. THE SURGEON USED THE SCREWDRIVER TO UNSCREW IT AND THE SCREW CAME OUT CUT AS WELL. THE SCREW COULD NOT BE REPLACED BECAUSE THE THREAD SHAFT OF THE SCREW WAS BOTHERING TO INSERT ANOTHER SCREW. FINALLY, THE SURGEON DECIDED TO ADD TWO MORE SCREWS AT THE SACRUM (BIGGER DIAMETER), CHANGE ONE SCREW USING A BIGGER DIAMETER, AND TO REPLACE TWO RODS. THIS REPORT IS FOR A EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 15311830 ↗