EXPEDIUM 179722745Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034070803), received between Sep 28, 2017 and Jun 17, 2020 — classified as 2 injuries, 1 malfunction.

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. 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.

• MalfunctionJun 17, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, AN EXPEDIUM DUAL INNIE SCREW WAS DETERMINED TO BE DEFECTIVE AND TWISTED. A NEW SCREW HAD TO BE USED IN ORDER TO PLACE THE ROD. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRTY (30) MINUTE DELAY. PATIENT STATUS WAS GOOD. THIS REPORT IS FOR AN EXPEDIUM POLYAXIAL SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10164940 ↗
• InjuryApr 26, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REMOVAL PROCEDURE DUE TO A BROKEN LEFT L5 PEDICLE/POLY SCREW UNDERNEATH THE TULIP. ORIGINALLY, THE PATIENT UNDERWENT L3-L5 POSTERIOR INSTRUMENTED FUSION ON (B)(6) 2011. HOWEVER, ON AN UNKNOWN DATE, THE SCREW WAS NOTED TO BE BROKEN. THUS, A HARDWARE REMOVAL WAS PERFORMED WHERE ALL SET SCREWS, ROD AND PEDICLE SCREWS WERE REMOVED AND WAS NOT REPLACED. NO FRAGMENTS WERE GENERATED FROM BROKEN DEVICE. HOWEVER, SCREWS WERE REMOVED WITH LITTLE DIFFICULTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. ORIGINAL EVENT DESCRIPTION: DR (B)(6), (B)(6) HOSPITAL, (B)(6) 2019. THE PATIENT HAD A BROKEN LEFT L5 PEDICLE SCREW, THE SCREW BROKE UNDERNEATH THE TULIP. THE PREVIOUS OPERATION WAS L3-L5 POSTERIOR INSTRUMENTED FUSION ON (B)(6) 2011 AT (B)(6) HOSPITAL. DR REMOVED ALL SET SCREWS, RODS AND PEDICLE SCREWS. NO SCREWS WERE REPLACED OR AVAILABLE FOR RETURN. UNKNOWN WHEN SCREW BROKE. PATIENT INITIALS: (B)(6).

  Patient problems: No Code Available

  MAUDE report 8556697 ↗
• InjurySep 28, 2017Break; Break

  BOTH SCREWS BROKE AFTER ABOUT 1 YEAR AFTER IMPLANTATION. 8X80 MM WAS USED AS ILIAC SCREW, 7X45 IN S1. REVISION SURGERY WAS NECESSARY TO REGAIN A STABLE SITUATION. QUESTION: ONLY FATIGUE FRACTURE OF THE SCREW OR MATERIAL DEFECT.

  Patient problems: Failure of Implant; Injury

  MAUDE report 6899976 ↗